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Maintain Regulatory and Financial Records

Maintain Regulatory and Financial Records

The key steps involved with maintaining regulatory and financial records include the following:

Problem Reports (Deviations and Adverse Events)

Problem Reports (Deviations and Adverse Events)

Carefully identify, document, resolve, and report any problems that occur throughout the study. Institutional Review Boards, Food and Drug Administration, and funding agencies each have specific timelines and guidelines for reporting these events, so check with your contacts to understand your responsibilities. They may provide you with an adverse event tracking log to submit, or you may need to create your own.

UW HUMAN SUBJECTS DIVISION
(206) 543-0098 | hsdinfo@uw.edu

FRED HUTCH INSTITUTIONAL REVIEW OFFICE
(206) 667-5900 | mnramire@fredhutch.org

SEATTLE CHILDREN’S INSTITUTIONAL REVIEW BOARD
(206) 987-7804 | irb@seattlechildrens.org

WESTERN IRB
(800) 562-4789 | clientservices@wirb.com

Maintain the Regulatory Binder

Maintain the Regulatory Binder

Maintain updated copies of protocol amendments, Institutional Review Board approvals, team changes, and training updates in your regulatory binder.

Please see the Pre-Study Preparation sections for Industry-Sponsored and Investigator-Initiated research for details on processes related to Setting Up the Study Binder.

Submit Protocol Amendments and Progress Reports

Submit Protocol Amendments and Progress Reports

If you need to make changes to your study after you obtain initial IRB approval, you will need to submit a request to modify, or amend, your study to the Institutional Review Board in advance of initiating the change. If you are working on an industry trial, confirm with the sponsor whether they will submit changes for you.

If you are conducting an investigator-initiated study and have a protocol, be sure to update this document with any applicable changes throughout the study (and change the version number and date with each revision).

UW HUMAN SUBJECTS DIVISION
(206) 543-0098 | hsdinfo@uw.edu

FRED HUTCH INSTITUTIONAL REVIEW OFFICE
(206) 667-5900 | mnramire@fredhutch.org

SEATTLE CHILDREN’S INSTITUTIONAL REVIEW BOARD
206-987-7804 | irb@seattlechildrens.org

If you are conducting an investigator-initiated Investigational New Drug or Investigational Device Exemption study, check with your Food and Drug Administration contact to determine if they also need to approve the protocol change.

If the changes will impact the study budget, you may need to contact UW Clinical Research Budget & Billing to re-negotiate budget and the UW Office of Sponsored Programs to re-negotiate the contract. Please see the Pre-Study Preparation sections for Industry-Sponsored and Investigator-Initiated research for details on processes related to Budget and Contracting.

You will receive the expiration date for your Institutional Review Board approval at the time of your initial approval, and with each subsequent continuing approval. This date will vary based on the study. Prior to your Institutional Review Board approval expiration date, you will need to submit a continuing review report to the Institutional Review Board. Follow the Institutional Review Board’s procedures for submitting the progress report within their stated timeframe.

UW HUMAN SUBJECTS DIVISION
(206) 543-0098 | hsdinfo@uw.edu
Study Closure Procedure

If you are conducting an investigator-initiated Investigational New Drug or Investigational Device Exemption study, check with your Food and Drug Administration contact to find out their requirements for Progress Report contents and timelines.

Check with your funding agency about their annual reporting requirements. For example, the National Institutes of Health requires reporting race/ethnicity stats for enrolled participants.

Monitoring Study Records

Monitoring Study Records

If you are working with industry, or if you are acting as a sponsor-investigator on an investigator-initiated Investigational New Drug or Investigational Device Exemption study, you will need to participate in monitoring visits throughout the study. This may be done in-person or remotely. If you have a data management center reviewing study data, be sure to prioritize quick turnarounds for data queries.

If your study does not have external monitoring, it is good practice to periodically review the data and regulatory records to ensure you are capturing data as planned and meeting your regulatory responsibilities. It may be helpful to consult an ITHS research monitor.

It may also be helpful to talk with a biostatistician about conducting interim data analysis.

If your study includes a Data and Safety Monitoring Board, understand their scope of work (usually in a charter, which you may receive a copy of) and meeting schedule, along with your role in providing information or responding to their inquiries.

Monitor the Budget

Monitor the Budget

Balancing costs, spending, and budgetary allowances at least monthly is paramount to staying on track.

  • If you are working with an industry sponsor, your final Clinical Trials Agreement (CTA) will specify what should be invoiced to the sponsor. Submit invoices to the sponsor within the timeframes outlined in the CTA. Please see the Institutional Oversight sections for Industry-Sponsored and Investigator-Initiated research for details on processes related to Contracting.
  • If you are working with a funding agency, check with the UW Office of Sponsored Programs and/or your department’s grants manager about budget spending restrictions, and for information on no-cost extensions.

UW OFFICE OF SPONSORED PROGRAMS
(206) 543-4043 | osp@uw.edu

Complete Refresher Trainings

Complete Refresher Trainings

Many funding agencies/sponsors have requirements to complete human subject protections and/or Good Clinical Practice refresher training. Check with your sponsor about expected time frames.

Please see the Pre-Study Preparation sections for Industry-Sponsored and Investigator-Initiated research for details on processes related to Human Subjects Protections Training.

Cite ITHSThe Institute is supported by grants UL1 TR002319, KL2 TR002317, and TL1 TR002318 from the NIH National Center for Advancing Translational Sciences through the Clinical and Translational Science Awards Program (CTSA).

Please help us continue to support your research by citing our grant number(s) in publications we supported.