Transition of Studies in Data Analysis Only and Long-Term Follow-Up into PittPRO

 

Studies that are in data analysis only (DAO) or long term follow up (LTFU) must transition into PittPRO unless a study closure is submitted. When continuing review is due, studies will transition into PittPRO rather than renewing in OSIRIS. If your study does not have an expiration date, please do not transition until you hear from HRPO.

Transition of DAO and LTFU follow a simplified process. Please follow the instructions below to avoid extra work. HRPO strongly encourages closure of studies that involve only analysis of de-identified data and any studies that otherwise no longer require IRB oversight.

 


Data Analysis Only

Sending subject-level data or overall study results to participants as approved in the IRB application or analysis of identified or de-identified data and/or specimens that were collected for research purposes are the only activities that can take place in the data analysis only state.

  • If the only activity taking place is sending results to participants, close the study and do not submit a transition.  
  • If the only activity taking place is analysis of de-identified data related to the aims of the main study, close the study and do not submit a transition.

Identifiable data and/or samples can be stored for future use without an active IRB approval. Subsequent requests to analyze the data and/or specimens for a different aim requires submission of a separate IRB application.

 

Long Term Follow-Up

The following activities can be done when a study reaches long term follow-up. Transition into PittPRO is required for these studies prior to expiration.

  • Review of medical records to collect data generated for clinical purposes
  • Verify survival status either through contact with the subject or a review of the National Death Index
  • Sending subject-level data or overall study results to participants as approved in the IRB application

 


Instructions to Transition to PittPRO

Follow these instructions exactly regardless of the study specifics. If you are unsure or have questions, contact askirb@pitt.edu.

  • Create a New Study
  • Basic Study Information page:
    • Complete each question
    • In question #8, upload a PDF of the current, approved OSIRIS application:
      • Open the study in OSIRIS
      • click “Reviewer Version”
      • save as PDF
  • Funding Sources page: provide all information
  • Study Team Members page: provide all information
  • Study Scope page: (follow these steps regardless of study specifics)
    • Mark #1, 2, 3, 4, 5, as N/A
    • Mark #6 with the appropriate response. Transitions do not go back to the scientific review group for review. This is for recordkeeping purposes only.
    • Mark #7, 8, 9 as “no”
    • Mark #10 as “yes,”
      • upload the OSIRIS Transition Continuing Review form that is found in the PittPRO Library
      • Include the OSIRIS PRO#.
    • Mark #11 as “no.”
  • Recruitment Methods: indicate “no”
  • For the remainder of the questions where there is a red asterisk, indicate “Data analysis only. See OSIRIS for details” or “Long term follow up only see OSIRIS for details.” If there is no red asterisk, leave the response blank.


Please contact us at askirb@pitt.edu with any questions. Thank you.


2/5/2020

Headline Teaser

Studies in the Data Analysis or Long-Term Follow-Up state in OSIRIS will need to transition to PittPRO