Legacy Submissions and the RAP - Making your Study Complete/Whole
Legacy studies are those that were not created in the IRB module of the research administration portal (RAP). If the parent study identification is all numbers with no letters, it is a legacy study (e.g., 01012015.099). If the parent study identification starts with "STUDY", it is a RAP study (e.g., STUDY99000999).
Because not all information for legacy studies was able to be migrated to the RAP, the first submission using the RAP for a legacy study will take some extra time and consideration. To make the study complete/whole in the RAP, information must be updated and all currently approved study materials uploaded. The only way to add/change information to the parent study in the RAP make the legacy study complete/whole is through a modification. When submitting a continuing review, you must submit a modification simultaneously if your legacy study has not been completed in the RAP (i.e., if you have not previously updated the legacy study information and uploaded legacy study materials via a RAP modification). Materials submitted through the RAP do not become part of the parent study unless submitted as a modification.
For additional information/guidance on migrated studies and the RAP:
- Transitioning studies to the RAP
- Guidance on how to make your study complete/whole for additional instructions.
Continuous protocol approval is required. At the time of initial review, a study is granted an approval period. The person listed as Principal Investigator (PI) is responsible for seeking and maintaining approval prior to continuing human subject research activities beyond the expiration date. If human subject research activities have concluded, the PI must properly close the study with RCS using the Study Closure Application.
To request continued approval and secure continued approval prior to the expiration date, the PI must provide the required materials in a timely manner. RCS requires continuation requests be submitted through the Research Administration Portal (RAP) at least 45 days in advance of the study’s expiration date.
Continued approval will need to be requested as follows:
- Exempt – Studies previously determined to qualify for exemption, must submit a Continuing Review Application form and a revised project end date will need to be provided. RCS will review the study to verify the study’s progress and determine that the study continues to qualify for exemption; a revised expiration date will be issued.
- Expedited and Full Review – Studies previously determined to require expedited or full review, must submit a Continuing Review Application form. The IRB must conduct a continuing review of the project annually, at minimum, and determine that all approval criteria specified in the federal regulations continue to be satisfied. If all criteria are satisfied, the IRB will issue continued approval with a new expiration date.
If you would like to request changes at the time of the Continuing Review request, the submission will also need to account for the proposed changes. For example, you can create a modification and continuing review in the RAP or you can create a separate modification submission for the changes that can be reviewed separately from the continuing review submission. See the Modification Review page for instructions on preparing a modification submission. Substantial changes should not be made at time of continuing review. Also see our application, forms, and guidance page.
Note About Enrollment Numbers:
A participant counts towards enrollment if they meet the definition of “human subject” at any point in their involvement.
- This includes someone who signs the consent document but does not complete the study.
- It also includes situations when researchers obtain identifiable private information or biospecimens about or from an individual, even if the researchers do not interact directly with the individual.
- Example: A potential participant who completes pre-screening prior to consent is not considered enrolled in the research unless the pre-screening data will also be used for research analyses or future research. However, if the pre-screening data will be used for research purposes or if an individual signs a consent form and there is further screening and screen fail at that point, that participant was enrolled and considered a withdrawal.
For flexibility, we recommend that researchers describe how many participants they plan to consent/enroll and how many participants they need to complete all study activities to achieve the aims. If needed, please consider submitting a separate modification or a MODCR (with other parts of the study selected in the scope) to revise your enrollment goals within your research plan.
For more information on the review process, approval periods, and average review times, see The Review Process: What To Expect.
For more information on preparing a Study Closure Application, see the Closing Your Protocol page.
If you have questions, please contact Research Compliance Services.
Applications to request continuous approval are submitted via the IRB module of the Research Administration Portal (RAP) by selecting the study from the system and completing a the "Create Modification/CR" activity. NOTE: On May 12, 2021 all legacy studies were migrated into the RAP. Going forward, legacy studies including continuing review requests will be managed through the RAP. For RAP guidance, see our RAP guidance page.