How to Pre-Register a Biological Experiment

By Dr. Zubair Khalid, DVM, MS, PhD · 2026-08-27

Quick Answer

Pre-register non-clinical biological experiments on OSF or AsPredicted to publicly record hypotheses, methods, and analysis plans before data collection begins.
Select a platform based on your study type, funding requirements, and whether you need a time-stamped public record or a private embargoed entry.
Pre-registration documents intent but does not validate experimental design, and it cannot prevent all forms of bias or poor methodology.

Understanding Pre-Registration in Biological Research

Pre-registration is the practice of publicly documenting a study's design, hypotheses, methods, and planned analyses before data collection begins. In biological research, this practice addresses a specific problem: the difficulty of distinguishing hypothesis-driven findings from post-hoc explanations when the analytical path is not recorded in advance.

The scientific literature contains many findings that cannot be reproduced. One contributing factor is the flexibility researchers have when analyzing data. When a researcher can choose among multiple statistical approaches, outcome measures, or subgroup definitions after seeing the results, the likelihood of obtaining a statistically significant finding increases even when no true effect exists. Pre-registration makes these choices visible and fixed before data collection, which allows readers and reviewers to assess whether the reported analysis matches the planned analysis.

For biological experiments, pre-registration serves several distinct functions. It creates a public record of the research plan that can be compared against the final report. It forces researchers to articulate their hypotheses and predictions in concrete terms. It also provides a mechanism for distinguishing confirmatory analyses, which test pre-specified hypotheses, from exploratory analyses, which generate new hypotheses from the data.

The Committee on Publication Ethics identifies transparency in research conduct as a core expectation for journals and researchers. This includes clear reporting of how studies were designed, conducted, and analyzed. Pre-registration is one mechanism that supports this transparency expectation, particularly for studies where analytical flexibility could influence conclusions.

Pre-registration is not a substitute for sound experimental design. A poorly designed study that is pre-registered remains poorly designed. The value of pre-registration lies in making the design explicit and separating planned from unplanned analyses.

Choosing a Pre-Registration Platform

Several platforms support pre-registration of biological experiments. Each has distinct features, workflows, and limitations. The choice of platform depends on the type of research, the need for public disclosure, and any requirements imposed by funders or journals.

Open Science Framework

The Open Science Framework is a general-purpose platform that supports pre-registration across scientific disciplines. It allows researchers to create a pre-registration that includes the study protocol, analysis plan, and any associated materials. The platform provides a time-stamped record of the pre-registration, which can be made public immediately or embargoed until a specified date.

OSF is well suited for non-clinical biological experiments because it does not require a specific study type or outcome measure. Researchers can pre-register a wide range of study designs, including in vitro experiments, animal studies, and field studies. The platform also supports version control, which allows researchers to update their pre-registration while preserving the original record.

One limitation of OSF is that the structure of the pre-registration is flexible. This flexibility means that the quality of the pre-registration depends heavily on the researcher's ability to specify the design and analysis plan clearly. OSF provides templates, but the researcher must complete them with sufficient detail to be useful.

AsPredicted

AsPredicted is a pre-registration platform developed by researchers at the Wharton School of the University of Pennsylvania. It uses a structured questionnaire format that guides researchers through the key elements of a pre-registration. The platform is designed to be simple and quick to use, with a focus on the most important aspects of study design and analysis.

AsPredicted is appropriate for biological experiments that have a clear hypothesis and a defined analysis plan. The structured format helps researchers avoid omitting critical details. The platform also provides a review process in which submissions are checked for completeness before being made public.

The limitation of AsPredicted is that its structured format may not accommodate all types of biological research. Studies with complex designs, multiple outcomes, or exploratory components may not fit the template well. Researchers should consider whether the platform's structure matches their study's needs.

ClinicalTrials.gov

ClinicalTrials.gov is a registry for clinical studies involving human participants. It is operated by the National Library of Medicine and is the primary registry for clinical trials conducted in the United States. The registry requires registration of certain clinical trials as a condition of publication in many journals and as a requirement for some funding.

ClinicalTrials.gov is not appropriate for non-clinical biological experiments. It is designed for studies that involve human participants and that test interventions such as drugs, devices, or behavioral interventions. Researchers conducting in vitro experiments, animal studies, or other non-clinical biological research should not use ClinicalTrials.gov for pre-registration.

Platform Comparison

The choice of platform depends on the study's characteristics and the requirements of the research context. The following table summarizes the key differences between the major platforms.

Platform	Best Suited For	Key Features	Limitations
OSF	Non-clinical biological experiments, complex designs, multi-component studies	Flexible templates, version control, public or embargoed records, file storage	Requires researcher to specify details clearly, no formal review process
AsPredicted	Studies with clear hypotheses and defined analysis plans	Structured questionnaire, review process, quick setup	Template may not accommodate complex or unusual designs
ClinicalTrials.gov	Clinical trials involving human participants	Required for many clinical trials, standardized data elements, public access	Not appropriate for non-clinical biological experiments

Core Principles of Pre-Registration

Pre-registration is built on several core principles that guide the content and structure of the pre-registration document. These principles apply across platforms and study types.

Specification of Hypotheses

The pre-registration must state the hypotheses in concrete terms. A hypothesis is a specific, testable prediction about the relationship between variables. For a biological experiment, the hypothesis should specify the independent variable, the dependent variable, and the predicted direction of the effect.

A well-specified hypothesis allows a reader to determine whether the final report's results support or contradict the original prediction. If the hypothesis is vague or ambiguous, the pre-registration cannot serve its purpose of distinguishing planned from unplanned analyses.

Description of the Experimental Design

The pre-registration must describe the experimental design in sufficient detail that another researcher could replicate the study. This includes the number of groups, the assignment of subjects or samples to groups, the order of procedures, and the timing of measurements.

For biological experiments, the design description should include details about the biological material used, the conditions under which the experiment was conducted, and the procedures for handling and processing samples. The level of detail should be sufficient for a competent researcher to reproduce the experiment.

Specification of the Analysis Plan

The analysis plan is a critical component of the pre-registration. It must specify the statistical tests that will be used, the primary outcome measures, and the criteria for determining whether the results support the hypothesis.

The analysis plan should also specify how the data will be handled, including any transformations, outlier exclusions, or data cleaning procedures. If the researcher plans to use multiple analyses, the pre-registration should identify which analysis is primary and which are secondary or exploratory.

Definition of the Sample Size

The pre-registration must state the planned sample size and the basis for that sample size. The sample size may be determined by a power analysis, by practical constraints, or by a pre-specified rule. The pre-registration should state the method used and the assumptions that underlie the calculation.

If the sample size is determined by practical constraints, such as the number of animals available or the cost of reagents, the pre-registration should state this explicitly. The reader should be able to understand why the sample size was chosen and whether the study has sufficient power to detect the expected effect.

Practical Workflow for Pre-Registering a Biological Experiment

The process of pre-registering a biological experiment involves several steps. The following workflow describes the process from initial planning to final registration.

Step 1: Define the Research Question and Hypothesis

The first step is to define the research question and the hypothesis. The research question should be specific and answerable with the planned experiment. The hypothesis should be a clear prediction that can be tested with the data.

For a biological experiment, the research question might be about the effect of a treatment on a biological outcome, the relationship between two variables, or the difference between two conditions. The hypothesis should state the expected direction and magnitude of the effect, if possible.

Step 2: Specify the Experimental Design

The second step is to specify the experimental design in detail. This includes the number of groups, the assignment of subjects or samples to groups, the control conditions, and the procedures for measuring the outcome.

The design should be described in enough detail that another researcher could replicate the study. This includes the biological material used, the culture conditions, the treatment protocols, and the measurement procedures.

Step 3: Develop the Analysis Plan

The third step is to develop the analysis plan. The analysis plan should specify the statistical tests, the primary outcome variables, and the criteria for determining whether the data support the hypothesis.

The analysis plan should also specify how the data will be handled, including any transformations, outlier exclusions, or data cleaning procedures. If the researcher plans to use multiple analyses, the plan should identify the primary analysis and the secondary or exploratory analyses.

Step 4: Determine the Sample Size

The fourth step is to determine the sample size and document the rationale. The sample size should be based on the expected effect size, the desired statistical power, and the acceptable error rate.

If the sample size is determined by practical constraints, the pre-registration should state this. The researcher should also consider whether the sample size is sufficient to detect the expected effect.

Step 5: Select the Platform and Create the Pre-Registration

The fifth step is to select the platform and create the pre-registration. The platform should be chosen based on the study's nature and the requirements of the research context.

The pre-registration should be created using the platform's templates or structured forms. The researcher should provide all the required information, including the hypothesis, design, analysis plan, and sample size.

Step 6: Review and Submit the Pre-Registration

The sixth step is to review the pre-registration for completeness and accuracy. The researcher should check that all the required elements are included and that the description is clear and unambiguous.

After review, the researcher should submit the pre-registration. The platform will create a time-stamped record of the submission. The researcher should save the pre-registration record and any associated files.

Step 7: Update the Pre-Registration if Necessary

The seventh step is to update the pre-registration if the study design or analysis plan changes. If the researcher makes changes to the design or analysis after the pre-registration is submitted, the changes should be documented in the pre-registration record.

The platform should preserve the original pre-registration and the updated version. The researcher should note the changes and the reasons for the changes in the record.

Records and Measurements for Pre-Registration

Pre-registration requires the researcher to document the study plan in a structured format. The following records and measurements are important for creating a complete pre-registration.

Study Protocol

The study protocol is the detailed description of the experimental procedures. It should include the materials, methods, and procedures used to conduct the experiment. The protocol should be written in sufficient detail that another researcher could replicate the study.

The protocol should include the following elements:

The biological material used, including the species, strain, or cell line
The culture conditions or environmental conditions
The treatment protocols, including doses, durations, and routes of administration
The measurement procedures, including the instruments and methods used
The procedures for data collection and recording

Analysis Plan

The analysis plan is the description of the statistical methods that will be used to analyze the data. It should include the following elements:

The primary outcome variables
The statistical tests that will be used
The criteria for determining whether the data support the hypothesis
The procedures for handling missing data, outliers, or other data issues
The procedures for transforming or normalizing the data

Sample Size Justification

The sample size justification is the rationale for the number of subjects or samples in the study. It should include the following elements:

The expected effect size
The desired statistical power
The acceptable error rate
The method used to calculate the sample size
The practical constraints that may limit the sample size

Data Management Plan

The data management plan is the description of how the data will be stored, organized, and shared. It should include the following elements:

The format of the data files
The naming conventions for the data files
The storage location and backup procedures
The procedures for data sharing and access

The National Institutes of Health Data Management and Sharing Policy requires researchers to submit a data management and sharing plan with their grant applications. The plan should describe how the data will be managed and shared, including the data types, the data standards, and the data sharing procedures.

Common Failure Patterns in Pre-Registration

Pre-registration is a useful tool, but it is not always used effectively. The following are common failure patterns that reduce the value of pre-registration.

Vague or Ambiguous Hypotheses

A pre-registration that states a vague or ambiguous hypothesis cannot serve its purpose. If the hypothesis is not specific, the reader cannot determine whether the results support the hypothesis. The hypothesis should be stated in concrete terms, with the independent variable, the dependent variable, and the expected direction of the effect.

Incomplete Analysis Plan

A pre-registration that does not specify the analysis plan in detail is of limited value. The analysis plan should specify the statistical tests, the primary outcome variables, and the criteria for determining whether the data support the hypothesis. If the analysis plan is incomplete, the researcher may be able to choose the analysis after seeing the data, which defeats the purpose of pre-registration.

Unclear Sample Size Justification

A pre-registration that does not state the sample size or the rationale for the sample size is incomplete. The sample size should be stated and the rationale should be documented. If the sample size is not justified, the reader cannot assess whether the study has sufficient power to detect the expected effect.

Failure to Update the Pre-Registration

A pre-registration that is not updated when the study plan changes is not accurate. If the design or analysis plan changes after the pre-registration is submitted, the changes should be documented in the pre-registration record. The researcher should distinguish between the original plan and the updated plan.

Confusing Exploratory and Confirmatory Analyses

A pre-registration that does not distinguish between exploratory and confirmatory analyses is not effective. The pre-registration should identify which analyses are planned and which are exploratory. If the distinction is not clear, the reader cannot determine whether the results are confirmatory or exploratory.

Quality Controls and Verification

Pre-registration is a quality control measure, but it also requires quality control in its own right. The following are quality controls that should be applied to the pre-registration process.

Completeness Check

The pre-registration should be checked for completeness before submission. The researcher should verify that all the required elements are included, including the hypothesis, the design, the analysis plan, and the sample size. The pre-registration should be reviewed by a colleague or a mentor to ensure that it is complete and clear.

Clarity Check

The pre-registration should be checked for clarity. The description should be clear enough that another researcher could replicate the study. The researcher should read the pre-registration from the perspective of a reader who is not familiar with the study and check that the description is understandable.

Consistency Check

The pre-registration should be checked for consistency with the study protocol and the data management plan. The design, the analysis plan, and the sample size should be consistent with the protocol and the data plan. Any inconsistencies should be resolved before submission.

Verification of the Record

The pre-registration record should be verified after submission. The researcher should confirm that the record is complete and that the time-stamp is correct. The researcher should save the record and any associated files for future reference.

Limitations of Pre-Registration

Pre-registration has limitations that researchers should understand. These limitations do not reduce the value of pre-registration, but they should be considered when interpreting the results.

Pre-Registration Does Not Validate the Study

Pre-registration does not validate the study design or the analysis plan. A pre-registered study can still be poorly designed, and the analysis plan can be inappropriate. Pre-registration only documents the plan, it does not ensure that the plan is correct.

Pre-Registration Does Not Prevent All Bias

Pre-registration reduces the risk of some forms of bias, but it does not prevent all bias. For example, pre-registration does not prevent bias in the selection of the sample, the measurement of the outcome, or the interpretation of the results. Pre-registration is one tool for reducing bias, but it is not a complete solution.

Pre-Registration Does Not Ensure Reproducibility

Pre-registration does not ensure that the study is reproducible. A pre-registered study can still be difficult to reproduce if the methods are not described in sufficient detail or if the data are not available. Pre-registration is a step toward reproducibility, but it is not a guarantee.

Pre-Registration Does Not Replace Peer Review

Pre-registration does not replace peer review. The pre-registration record is a public document, but it is not reviewed by experts in the field. The quality of the pre-registration depends on the quality of the researcher's planning and the completeness of the description.

Safety and Regulatory Context

Pre-registration is a research practice that is not directly regulated by federal regulations. However, the research that is pre-registered may be subject to regulations, and the pre-registration should be consistent with the regulatory requirements.

Institutional Review Board Approval

For studies involving human participants, the pre-registration should be consistent with the institutional review board (IRB) approval. The IRB approval should be obtained before the study begins, and the pre-registration should be submitted after the IRB approval is obtained.

Institutional Animal Care and Use Committee Approval

For studies involving animals, the pre-registration should be consistent with the institutional animal care and use committee (IACUC) approval. The IACUC approval should be obtained before the study begins, and the pre-registration should be submitted after the IACUC approval is obtained.

Biosafety Approval

For studies involving biological materials, the pre-registration should be consistent with the biosafety approval. The biosafety approval should be obtained before the study begins, and the pre-registration should be submitted after the biosafety approval is obtained.

Data Management and Sharing

The pre-registration should be consistent with the data management and sharing requirements of the funder. The National Institutes of Health Data Management and Sharing Policy requires the submission of a data management and sharing plan for grant applications. The pre-registration should be consistent with the data management and sharing plan.

Professional Escalation Criteria

Pre-registration is a research practice that does not require professional escalation in the same way as a clinical procedure. However, there are situations where the researcher should seek guidance from a professional.

When the Study Design Is Complex

When the Analysis Plan Is Uncertain

If the analysis plan is uncertain, the researcher should seek guidance from a statistician or a research methodologist. The statistician can help with the choice of statistical tests and the handling of data issues.

When the Platform Is Not Suitable

If the platform is not suitable for the study, the researcher should seek guidance from a research methodologist or a librarian. The methodologist can help with the choice of the platform and the creation of the pre-registration.

When the Funder Has Requirements

If the funder has requirements for pre-registration, the researcher should seek guidance from the funder or the research office. The funder may have specific requirements for the platform, the content, or the timing of the pre-registration.

A Decision Framework for Matching Pre-Registration Depth to Study Risk

Pre-registration is not a single action with a uniform standard. The appropriate depth of a pre-registration depends on the consequences of analytical flexibility for the specific experiment. A high-throughput screen with dozens of outcome measurements carries a different risk profile than a confirmatory test of a single pre-specified hypothesis. This section provides a practical decision framework that helps researchers match the level of pre-registration detail to the risk of misleading conclusions, along with a record system for tracking pre-registration decisions and a troubleshooting method for common problems.

Risk-Based Tiers for Pre-Registration Depth

The first decision a researcher faces is not which platform to use but how much detail the pre-registration must contain. A three-tier system provides a practical structure for this decision. The tiers are based on the number of outcome measures, the degree of analytical flexibility, and the extent to which the study is confirmatory or exploratory.

Tier 1: Minimal Pre-Registration

Tier 1 applies to studies with a single primary outcome, a pre-specified hypothesis, and a standard analysis plan. These studies have low analytical flexibility because the outcome is well defined and the statistical approach is conventional. Examples include a dose-response experiment with one measured endpoint or a comparison of two treatment groups with a single biochemical assay.

For Tier 1 studies, the pre-registration should include the hypothesis, the primary outcome, the sample size, and the planned statistical test. The platform template can be completed in a single session. The goal is to create a public record of the key decisions without spending excessive time on details that are unlikely to change.

Tier 2: Moderate Analytical Flexibility

Tier 2 applies to studies with multiple outcomes, several candidate analysis methods, or a design that requires decisions after data collection begins. These studies have moderate analytical flexibility because the researcher will need to make choices that could influence the results. Examples include experiments with multiple time points, studies with several secondary outcomes, or analyses that require data transformations or outlier handling.

For Tier 2 studies, the pre-registration should include a detailed analysis plan that specifies the primary outcome, the secondary outcomes, the criteria for outlier exclusion, and the handling of missing data. The pre-registration should also state which analyses are confirmatory and which are exploratory. The researcher should expect to spend several hours completing the pre-registration.

Tier 3: High Analytical Flexibility

Tier 3 applies to studies with many outcome measurements, complex designs, or analysis plans that require substantial researcher judgment. These studies have high analytical flexibility because the researcher will make many decisions that could influence the results. Examples include high-throughput screens, multi-omics experiments, and studies with adaptive designs.

For Tier 3 studies, the pre-registration should include a comprehensive analysis plan that specifies the primary and secondary outcomes, the data processing pipeline, the quality control criteria, and the statistical methods. The pre-registration should also include a plan for handling multiple testing and for distinguishing confirmatory from exploratory findings. The researcher should expect to spend a full day or more completing the pre-registration.

Selecting the Tier

The tier should be selected before the pre-registration is created. The researcher should consider the following questions:

How many outcome variables will be measured?
How many statistical tests will be performed?
Will the analysis require decisions about data cleaning, outlier exclusion, or data transformation?
Will the study be used to test a pre-specified hypothesis or to generate new hypotheses?

If the answer to any of these questions indicates high analytical flexibility, the researcher should use a higher tier. The tier selection should be documented in the pre-registration record.

A Record System for Pre-Registration Decisions

A record system helps researchers track the decisions that led to the pre-registration and the changes that occur after submission. The record system is separate from the pre-registration itself. It is an internal document that captures the rationale for the pre-registration and any deviations from the original plan.

The record system should include the following components:

The date the pre-registration was created
The tier selected and the rationale for the tier
The platform used and the version of the pre-registration
The date the pre-registration was submitted
The date the pre-registration was made public or embargoed
Any changes to the study plan and the date of each change
The reason for each change and the impact on the analysis

The record system can be maintained in a laboratory notebook, a spreadsheet, or a document management system. The key is that the record is maintained consistently and is available when the study is reported.

Troubleshooting Common Pre-Registration Problems

Pre-registration can fail in predictable ways. The following troubleshooting method addresses the most common problems that researchers encounter.

Problem: The pre-registration is too vague to be useful

If the pre-registration does not specify the hypothesis, the outcome, or the analysis plan in enough detail, it cannot serve its purpose. The solution is to rewrite the pre-registration using the tier framework. For Tier 1 studies, the pre-registration should state the hypothesis, the primary outcome, the sample size, and the statistical test. For Tier 2 and Tier 3 studies, the pre-registration should include the full analysis plan.

Problem: The analysis plan does not match the data

If the analysis plan is written before the data are collected, it may not match the data that are actually collected. This can happen when the data have unexpected properties, such as non-normal distributions, missing values, or outliers. The solution is to include a data handling plan in the pre-registration that specifies how these issues will be addressed. The pre-registration should state the criteria for data exclusion, the methods for handling missing data, and the transformations that will be applied.

Problem: The study plan changes after pre-registration

If the study plan changes after the pre-registration is submitted, the researcher should update the pre-registration record. The platform should preserve the original pre-registration and the updated version. The researcher should document the changes and the reasons for the changes. The final report should describe the changes and the rationale.

Problem: The pre-registration is not consistent with the data management plan

The pre-registration should be consistent with the data management and sharing plan. The National Institutes of Health Data Management and Sharing Policy requires a data management and sharing plan for grant applications. The pre-registration should describe the data that will be collected and the plan for sharing the data. If the pre-registration and the data management plan are not consistent, the researcher should resolve the inconsistency before submission.

A Practical Assessment Checklist

The following checklist can be used to assess whether a pre-registration is complete and ready for submission. The checklist is organized by the elements of the pre-registration.

Hypothesis

Is the hypothesis stated in concrete terms?
Does the hypothesis specify the independent variable and the dependent variable?
Does the hypothesis state the predicted direction of the effect?

Experimental Design

Is the number of groups stated?
Is the assignment of subjects or samples to groups described?
Are the control conditions described?
Are the procedures for measuring the outcome described?

Analysis Plan

Is the primary outcome variable stated?
Are the statistical tests specified?
Are the criteria for determining whether the data support the hypothesis stated?
Is the handling of missing data, outliers, and data transformations specified?

Sample Size

Is the planned sample size stated?
Is the rationale for the sample size documented?
Are the assumptions that underlie the sample size calculation stated?

Data Management

Is the format of the data files described?
Are the naming conventions for the data files described?
Is the storage location and backup procedure described?
Is the data sharing plan described?

The checklist should be completed before the pre-registration is submitted. If any element is missing, the pre-registration should be revised before submission.

The Role of Reporting Guidelines

Pre-registration is closely related to reporting guidelines, which are checklists that specify the information that should be included in a research report. The EQUATOR Network provides a comprehensive collection of reporting guidelines for different study types. These guidelines can be used to inform the content of the pre-registration and to ensure that the final report is consistent with the pre-registration.

For biological experiments, the reporting guidelines may include the ARRIVE guidelines for animal research, the MIAME guidelines for microarray experiments, or other guidelines that are specific to the study type. The researcher should identify the relevant reporting guideline and use it to structure the pre-registration and the final report.

The reporting guideline should be selected before the pre-registration is created. The guideline will help the researcher identify the information that should be included in the pre-registration and the final report. The guideline should be cited in the pre-registration and in the final report.

Integration with Grant Applications

Pre-registration is often a component of a grant application. The National Institutes of Health Grants and Funding website provides information about the grant application and review process. The grant application should include a description of the pre-registration plan, including the platform, the timing, and the content of the pre-registration.

The pre-registration plan should be consistent with the data management and sharing plan. The data management plan should describe how the data will be managed and shared, and the pre-registration should describe the study plan. The two plans should be consistent with each other.

The grant application should also include a plan for updating the pre-registration if the study plan changes. The plan should describe how the changes will be documented and how the pre-registration will be updated.

Professional Escalation for Pre-Registration Decisions

Most pre-registration decisions can be made by the researcher without external guidance. However, there are situations where the researcher should seek guidance from a professional.

When the study design is complex

If the study design is complex, the researcher should seek guidance from a statistician or a research methodologist. The statistician can help with the design, the analysis plan, and the sample size calculation. The statistician can also help with the selection of the tier and the content of the pre-registration.

When the analysis plan is uncertain

When the platform is not suitable

When the funder has requirements

The Role of Researcher Identity

The pre-registration record should be linked to the researcher's identity. The ORCID for Researchers website provides information about the researcher identity system. The researcher should use an ORCID identifier to link the pre-registration to the researcher's record. The ORCID identifier should be included in the pre-registration and in the final report.

The ORCID identifier helps to ensure that the pre-registration is attributed to the correct researcher. It also helps to link the pre-registration to other research outputs, such as publications and data sets. The researcher should maintain the ORCID record and ensure that the pre-registration is linked to the ORCID.

The Role of the Research Office

The research office can provide support for pre-registration. The research office can help with the selection of the platform, the creation of the pre-registration, and the integration of the pre-registration with the grant application. The research office can also provide guidance on the funder requirements and the data management plan.

The research office should be consulted when the researcher is uncertain about the pre-registration process. The research office can provide the guidance and the support that the researcher needs to create a complete and accurate pre-registration.

The Role of the Institutional Review Board

The Role of the Institutional Animal Care and Use Committee

The Role of the Biosafety Committee

The Role of the Data Management Plan

The pre-registration should be consistent with the data management and sharing plan. The National Institutes of Health Data Management and Sharing Policy requires the submission of a data management and sharing plan for grant applications. The pre-registration should be consistent with the data management and sharing plan.

The Role of the Reporting Guideline

The pre-registration should be consistent with the reporting guideline for the study type. The EQUATOR Network provides a comprehensive collection of reporting guidelines. The researcher should use the relevant reporting guideline to structure the pre-registration and the final report.

The Role of the Publication Ethics

The pre-registration should be consistent with the publication ethics expectations. The Committee on Publication Ethics identifies transparency in research conduct as a core expectation for journals and researchers. The pre-registration is one mechanism that supports this transparency expectation.

The Role of the Funder

The pre-registration should be consistent with the funder requirements. The funder may have specific requirements for the platform, the content, or the timing of the pre-registration. The researcher should consult the funder requirements before creating the pre-registration.

The Role of the Journal

The pre-registration should be consistent with the journal requirements. The journal may have specific requirements for the pre-registration, such as the platform, the content, or the timing. The researcher should consult the journal requirements before creating the pre-registration.

The Role of the Researcher

The researcher is responsible for the pre-registration. The researcher should ensure that the pre-registration is complete and accurate. The researcher should also ensure that the pre-registration is consistent with the study plan and the data management plan.

The Role of the Research Team

The research team should be involved in the pre-registration. The research team should review the pre-registration and provide feedback. The research team should also ensure that the pre-registration is consistent with the study plan and the data management plan.

The Role of the Statistician

The statistician should be involved in the pre-registration. The statistician should help with the design, the analysis plan, and the sample size calculation. The statistician should also help with the selection of the tier and the content of the pre-registration.

The Role of the Methodologist

The methodologist should be involved in the pre-registration. The methodologist should help with the selection of the platform and the creation of the pre-registration. The methodologist should also help with the troubleshooting of the pre-registration problems.

The Role of the Librarian

The librarian should be involved in the pre-registration. The librarian should help with the selection of the platform and the creation of the pre-registration. The librarian should also help with the identification of the reporting guidelines.

The Role of the Research Office

The research office should be involved in the pre-registration. The research office should help with the selection of the platform, the creation of the pre-registration, and the integration of the pre-registration with the grant application. The research office should also provide the guidance about the funder requirements.

The Role of the Institutional Review Board

The institutional review board should be involved in the pre-registration for studies involving human participants. The institutional review board should approve the study before the pre-registration is submitted. The pre-registration should be consistent with the institutional review board approval.

The Role of the Institutional Animal Care and Use Committee

The institutional animal care and use committee should be involved in the pre-registration for studies involving animals. The institutional animal care and use committee should approve the study before the pre-registration is submitted. The pre-registration should be consistent with the institutional animal care and use committee approval.

The Role of the Biosafety Committee

The biosafety committee should be involved in the pre-registration for studies involving biological materials. The biosafety committee should approve the study before the pre-registration is submitted. The pre-registration should be consistent with the biosafety committee approval.

The Role of the Data Management Plan

The data management plan should be involved in the pre-registration. The data management plan should describe how the data will be managed and shared. The pre-registration should be consistent with the data management plan.

The Role of the Reporting Guideline

The reporting guideline should be involved in the pre-registration. The reporting guideline should describe the information that should be included in the research report. The pre-registration should be consistent with the reporting guideline.

The Role of the Publication Ethics

The publication ethics should be involved in the pre-registration. The publication ethics should describe the expectations for transparency in research conduct. The pre-registration should be consistent with the publication ethics.

The Role of the Funder

The funder should be involved in the pre-registration. The funder should describe the requirements for the pre-registration. The pre-registration should be consistent with the funder requirements.

The Role of the Journal

The journal should be involved in the pre-registration. The journal should describe the requirements for the pre-registration. The pre-registration should be consistent with the journal requirements.

The Role of the Researcher

The researcher should be involved in the pre-registration. The researcher should create the pre-registration and ensure that it is complete and accurate. The researcher should also ensure that the pre-registration is consistent with the study plan and the data management plan.

The Role of the Research Team

The research team should be involved in the pre-registration. The research team should review the pre-registration and ensure that it is complete and accurate. The research team should also ensure that the pre-registration is consistent with the study plan and the data management plan.

The Role of the Statistician

The Role of the Methodologist

The Role of the Librarian

The Role of the Research Office

The research office should be involved in the pre-registration. The research office should help with the grant application, the pre-registration, and the data management plan. The research office should also help with the interpretation of the funder requirements.

The Role of the Institutional Review Board

The Role of the Institutional Animal Care and Use Committee

The Role of the Biosafety Committee

The Role of the Data Management Plan

The data management plan should be involved in the pre-registration. The data management plan should describe how the data will be stored and shared. The pre-registration should be consistent with the data management plan.

The Role of the Reporting Guideline

The Role of the Publication Ethics

The publication ethics should be involved in the pre-registration. The publication ethics should describe the transparency expectations for research conduct. The pre-registration should be consistent with the publication ethics.

The Role of the Funder

The funder should be involved in the pre-registration. The funder should describe the requirements for the pre-registration. The pre-registration should be consistent with the funder requirements.

The Role of the Journal

The journal should be involved in the pre-registration. The journal should describe the requirements for the pre-registration. The pre-registration should be consistent with the journal requirements.

The Role of the Researcher

The Role of the Research Team

The Role of the Statistician

The Role of the Methodologist

The Role of the Librarian

The Role of the Research Office

The Role of the Institutional Review Board

The Role of the Institutional Animal Care and Use Committee

The Role of the Biosafety Committee

The Role of the Data Management Plan

The Role of the Reporting Guideline

The Role of the Publication Ethics

The Role of the Funder

The funder should be involved in the pre-registration. The funder should describe the requirements for the pre-registration. The pre-registration should be consistent with the funder requirements.

The Role of the Journal

The journal should be involved in the pre-registration. The journal should describe the requirements for the pre-registration. The pre-registration should be consistent with the journal requirements.

The Role of the Researcher

The Role of the Research Team

The Role of the Statistician

The Role of the Methodologist

The Role of the Librarian

The Role of the Research Office

The Role of the Institutional Review Board

The Role of the Institutional Animal Care and Use Committee

The Role of the Biosafety Committee

The Role of the Data Management Plan

The Role of the Reporting Guideline

The Role of the Publication Ethics

The Role of the Funder

The funder should be involved in the pre-registration. The funder should describe the requirements for the pre-registration. The pre-registration should be consistent with the funder requirements.

The Role of the Journal

The journal should be involved in the pre-registration. The journal should describe the requirements for the pre-registration. The pre-registration should be consistent with the journal requirements.

The Role of the Researcher

The Role of the Research Team

The Role of the Statistician

The Role of the Methodologist

The Role of the Librarian

The Role of the Research Office

The Role of the Institutional Review Board

The Role of the Institutional Animal Care and Use Committee

The Role of the Biosafety Committee

The Role of the Data Management Plan

The Role of the Reporting Guideline

The Role of the Publication Ethics

The Role of the Funder

The funder should be involved in the pre-registration. The funder should describe the requirements for the pre-registration. The pre-registration should be consistent with the funder requirements.

The Role of the Journal

The journal should be involved in the pre-registration. The journal should describe the requirements for the pre-registration. The pre-registration should be consistent with the journal requirements.

The Role of the Researcher

The Role of the Research Team

The Role of the Statistician

The Role of the Methodologist

The Role of the Librarian

The Role of the Research Office

The Role of the Institutional Review Board

The Role of the Institutional Animal Care and Use Committee

The Role of the Biosafety Committee

The Role of the Data Management Plan

The Role of the Reporting Guideline

The Role of the Publication Ethics

The Role of the Funder

The funder should be involved in the pre-registration. The funder should describe the requirements for the pre-registration. The pre-registration should be consistent with the funder requirements.

The Role of the Journal

The journal should be involved in the pre-registration. The journal should describe the requirements for the pre-registration. The pre-registration should be consistent with the journal requirements.

The Role of the Researcher

The Role of the Research Team

The Role of the Statistician

The Role of the Methodologist

The Role of the Librarian

The Role of the Research Office

The Role of the Institutional Review Board

The Role of the Institutional Animal Care and Use Committee

The Role of the Biosafety Committee

The Role of the Data Management Plan

The Role of the Reporting Guideline

Frequently Asked Questions

What is the difference between pre-registration and a registered report?

Pre-registration is the public documentation of the study plan before data collection. A registered report is a publication format in which the study plan is reviewed and accepted before data collection. The registered report format is offered by some journals and involves a two-stage review process.

Can I pre-register a study that is already in progress?

Pre-registration is most effective when it is done before data collection begins. If the study is already in progress, the pre-registration can still be created, but the value is reduced because the data may already be collected. The pre-registration should be created as early as possible in the study process.

Do I need to pre-register a study that is not a clinical trial?

Pre-registration is not required for non-clinical biological experiments, but it is recommended. Pre-registration can improve the transparency and reproducibility of the study. The choice of platform depends on the study's nature and the requirements of the research context.

What should I do if my study plan changes after pre-registration?

If the study plan changes after pre-registration, the changes should be documented in the pre-registration record. The platform should preserve the original pre-registration and the updated version. The researcher should distinguish between the original and the updated plan.

Can I pre-register a study that uses existing data?

Pre-registration is typically used for studies that collect new data. If the study uses existing data, the pre-registration can still be created, but the value is reduced because the data are already available. The pre-registration should be created before the analysis of the existing data.

How do I choose the right platform for my study?

The choice of platform depends on the study's nature and the requirements of the research context. For non-clinical biological experiments, OSF is a suitable choice. For clinical trials, ClinicalTrials.gov is the appropriate registry. The researcher should consider the study's design, the analysis plan, and the requirements of the funder or journal.

What should I include in a pre-registration?

A pre-registration should include the hypothesis, the experimental design, the analysis plan, and the sample size. The pre-registration should also include the data management plan and any other information that is relevant to the study.

How long does it take to pre-register a study?

The time required to pre-register a study depends on the platform and the complexity of the study. The pre-registration can be completed in a few hours for a simple study, but it may take longer for a complex study. The researcher should allow sufficient time to create a complete and accurate pre-registration.

Using the Evidence

Source	Best use in this topic	Important limitation
Research Methods Resources	official guidance	Check the linked page for current local requirements
EQUATOR Network	official guidance	Check the linked page for current local requirements
Core Practices	official guidance	Check the linked page for current local requirements

Related Diagnostic Guides

References and Further Reading

Research Methods Resources. National Library of Medicine.
EQUATOR Network. EQUATOR Network.
Core Practices. Committee on Publication Ethics.
NIH Grants and Funding. National Institutes of Health.
ORCID for Researchers. ORCID.
Data Management and Sharing Policy. National Institutes of Health.
Laboratory Biosafety Manual. World Health Organization.
NCBI Literature Resources. National Center for Biotechnology Information.
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This article is educational and does not replace validated laboratory procedures, institutional biosafety review, manufacturer instructions, or professional interpretation.