Other - Research Compliance Network Forum

FDA INDSR Review Policy

alyssapingitore — Mon, 22 Dec 2025 20:08:30 +0000

Hi all, I'm looking to learn more about how your institutions are addressing new contents of the December 2025 FDA "Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices". There is a new statement that was not previously included in the 2012 version: "The investigator should review all IND safety reports received from sponsors as a part of the investigator’s responsibility to protect the rights, safety, and welfare of trial participants (see § 312.60)."

If your institution allows the investigator of an externally sponsored study to delegate review of INDSRs to another qualified member of the study team, and the PI only personally reviews those that meet the definition for UAP, how are you interpreting this new statement?

Accessing other ICFs for Research

Sbrowning — Fri, 05 Dec 2025 22:00:21 +0000

We have a graduate student that would like to use approved informed consent forms (not signed by participants, only the consent form) to answer a research question and has requested access to these from the IRB. The consents would be from any sponsor (industry, investigator, federal etc...) Can you tell me if you have ever had such a request and how you managed the access to the ICFs?

Comparison of Research Regulations

oostls — Fri, 05 Sep 2025 19:15:49 +0000

Hello,

I have been tasked with creating a document that compares FDA, ICH-GCP, and HHS research regulations. Is there anyone in the forum that has already creating such a document? If so, would you be willing to share it with me?

Thank you!

Lori Oosterman

Corewell Health Research Compliance

Novelution, Kuali, or InfoEd users?

sasamoke — Tue, 29 Jul 2025 18:39:31 +0000

Hello,

Are there any institutions using Novelution, Kuali, or InfoEd for their electronic IRB platform? The University of Michigan is currently looking at a new vendor for our IRB platform and wanted to hear from peer institutions who are using these platforms.

Wearables, phone apps, algorithms

LDSchaffer — Mon, 28 Jul 2025 14:54:37 +0000

Our IRB has seen an increase in investigator-initiated studies that are utilizing wearables, phone apps, algorithms, etc where data may be going out of the research/academic institution (e.g. Apple watch, or third-party phone app). Most studies are minimal risk, with data privacy considerations being the primary risk. We are benchmarking how institutional IRBs are reviewing similar studies and navigating any institutional requirements that may fall outside of the IRB purview (e.g. IT security or privacy/security office). We are specifically interested in how institutions navigate data privacy considerations for research studies where there will not be a contract in place with outside company (e.g. Apple, FitBit).

-What information is required for IRB review?

-How does the IRB handle the data privacy risks? e.g. disclosing in the consent form or utilizing required template language? Template language?

-Does the institution have specific requirements for reviews outside of IRB related to data privacy and security? If so, does that review occur in parallel with IRB? Before IRB review?

-Does the institution make the decision on whether the study can be conducted based on the data privacy risks?

Any policies or procedural information you can share would be greatly appreciated!

Thank you,

Lisa Schaffer

lisa.schaffer@louisville.edu

Corrective Action Plans

LDSchaffer — Fri, 18 Jul 2025 15:17:42 +0000

I am looking at revising our corrective action plan template and helping the study team identify the root cause for their error. Does anyone have a corrective action plan template or guidance that they love and would be willing to share?

AVOCA

cindyfontenelle — Tue, 15 Jul 2025 14:36:48 +0000

Are any of your facilities a member of AVOCA? Any opinions of the service? Thank you.

What is your institution's process to choose studies to audit/review?

osodesina — Mon, 10 Mar 2025 18:02:35 +0000

Hello All,

By way of brief introduction, my name is Sola, I am a HRPP Education and Compliance Specialist at Baystate Health in Springfield, MA.

I have a question for the community which I am hoping may spark an informative and engaging conversation.

How does your institution decide which not for cause studies to review/audit? I am curious about the process on selecting these studies. Is it randomized, if so how do you randomized? Do you pick a risk factor, if so how do you pick the risk factor?

A little about Baystate, we are a multi-hospital institution with a small research portfolio. Some PIs have a larger portfolio than others, their names may come up more often. We would like to be fair in our process when selecting studies. We want to ensure we are engaging with all PIs conducting research.

We are in the process of program evaluation to assure that we are selecting studies in a fair and equitable fashion.

I look forward to this engaging conversation.

Have a great day,

Sola

Oncology CRC Training Timeline

bmartin@gjhosp.org — Mon, 03 Mar 2025 22:53:04 +0000

My experience has been it takes about 6-12 months for a CRC to be competent enough to be independently doing Oncology Phase 2+ Industry trials. If they have a life science degree and medical/clinical experience, the training is around 6-9 months. If they only have one or the other, it seems to be closer to 12 months. *Note: At our site the CRC wears all the hats! (coordinator, data, regulatory, specimen processing, sponsor billing and subject billing liaison)

In your experience, is this a reasonable timeline? What are your experiences/expectations? If you have a similar CRC set up and you have a reduced training timeline, with high quality output, would you be willing to share your training plan?

Thanks in advance!

Brandy Martin, CCRP, CHRC

Research Manager

Network Oversight Policy for Clinical Research

CZwieg — Mon, 24 Feb 2025 19:34:34 +0000

Hello all,

I am creating a Network Oversight Policy for clinical research conducted at our network sites and was wondering if anyone had a similar policy, as I am struggling to locate examples.

Thanks for your help!