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CLINICAL RESEARCH STEERING COMMITTEE

Meeting Minutes

Informed Consent Form (ICF) for Autopsy/Postmortem

Meeting Date:

July 24, 2024

Meeting Type:

CRSC Meeting

Prepared By:

Lisa Mulder (Admin)

ATTENDEES

Leticia Tarilonte

CRSC Chair

Kristina Johnson

CRSC member

Nathalie Riebel

CRSC member

Phill Gallacher

CRSC member

Sylvain Bedard

CRSC Co-Chair

Suzanne Plezier

CRSC Chair

Lisa Mulder

Admin

AGENDA / KEY QUESTIONS

01

What are the “do’s and don’ts” or key considerations when creating an ICF related to autopsy / postmortem?

02

CTIS process: what are past experiences, lessons learned, and considerations when submitting to CTIS and what roles are delegated to CROs?

03

What are potential ways to accelerate IRB and IBC submission and approval?

04

What are past experiences related to blood collection methods, tubes, volumes and IRB/EC feedback for younger populations?

KEY TAKEAWAYS

Autopsy ICF: Key Considerations

Implementation of an autopsy ICF might depend on the optional or mandated nature of the autopsy.

What are the “do’s and don’ts” or key considerations when creating an ICF related to autopsy / postmortem

Key Discussion Notes:

  • Implementation of an autopsy ICF might depend on the optional or mandated nature of the autopsy.
  • One CRSC member reflected on an instance where autopsy/postmortem sample collection was mandated by the FDA and the respective language needed to be kept at the site-level ICF despite push back from some sites. In this case tissue collection was part of a Special Protocol Assessment (SPA).
  • A SPA is more common at the end of a phase II.
  • In other instances, the attendees aligned that having the optional autopsy language inserted in the main ICF with a tick box is best.
  • Alternatively, the main ICF can mention that a separate postmortem ICF will be provided to the patient.
  • Most participants or caregivers (for pediatric participants) are very familiar with the disease under study and the postmortem ICF might not come as a surprise.
  • Not every country may be supportive of an autopsy. US, UK and the Netherlands seem to have no problems. Germany is OK; however, Spain might have considerations.
  • The CRSC members provided general suggestions to involve patient advocacy groups to help craft sensitive and acceptable language.
  • Cadaver research is more common in academia and may not require full subject consent post-mortem under 45 CFR 46.
  • It is recommended to introduce a procedure protocol (mini protocol) with instructions on what tissues are to be collected and how to process samples. It’s important to identify the priority list when it comes to tissue collection.
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CTIS Submission: Lessons & CRO Roles

The group shared experiences with the EMA’s Clinical Trials Information System (CTIS), focusing on sponsor vs. CRO roles and submission strategies.

CTIS process: what are past experiences, lessons learned, and considerations when submitting to CTIS and what roles are delegated to CROs

The group shared experiences with the EMA’s Clinical Trials Information System (CTIS), focusing on sponsor vs. CRO roles and submission strategies.

Key Discussion Notes:

  • Most CRSC members delegate full CTIS admin roles (full access) to CROs due to their expertise and sponsor resource limitations.
  • Some countries (e.g., Italy, India) require sponsors to register studies directly.
  • CROs have the most experience and no major concerns were reported.
  • One CRO had created a guidance document to be completed by the Sponsor to streamline the CTIS submission process.
  • Depending on the countries involved and the number of EU countries, the team recommended initiating submission with a single-country submission (e.g., Bulgaria) for a faster initial approval.
  • Other countries can be added as amendments.
  • In addition to Bulgaria, Germany and Spain were cited as favorable (fast) Reporting Member States (RMS).

Other Notes:

  • Emphasis on early strategic planning to avoid delays.
  • Regulatory teams play a critical role in navigating country-specific requirements.
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Accelerating IRB & IBC Approvals

The team discussed strategies to streamline Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) approvals, especially for gene therapy studies.

What are potential ways to accelerate IRB and IBC submission and approval

The team discussed strategies to streamline Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) approvals, especially for gene therapy studies.

Key Discussion Points:

Expect Delays:

  • Always plan for at least two rounds of IRB review.
  • Gene therapy and pediatric studies often require additional specialty boards (e.g., radiology, pharmacy).

Proactive Preparation:

  • Engage with IRB early and request in advance a list of required documents.
  • Prepare manuals for procedures (e.g., bone marrow aspiration, intrathecal administration).
  • Submit required documents and have supporting documents ready so that the team can respond quickly to information requests.

IRB Recommendations:

  • BRANY (New York-based) was recommended for its integrated IRB/IBC review.
  • Advarra and Sabai were also mentioned as reliable central IRB options.

Communication:

  • Sponsors and CRO to collaborate (e.g., use of checklist) to ensure complete submissions.
  • Avoid delays by submitting comprehensive documentation from the start.
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Blood Collection in Pediatric Studies

Use baby butterfly needles to minimize vein collapse. Foot veins are often more accessible than arm veins in infants.

What are past experiences related to blood collection methods, tubes, volumes and IRB/EC feedback for younger populations

Key Discussion Points:
Technical Tips:

  • Use baby butterfly needles to minimize vein collapse.
  • Foot veins are often more accessible than arm veins in infants.

Volume Management:

  • Reference charts exist for blood volume limits over 24 hours and 30 days.
  • Prioritize critical tests and provide sites with a sample collection order list.
  • Use microtubes. Children’s hospitals are very familiar with smaller collection tubes and testing on smaller volumes. Central labs are not used to working with smaller volumes.
  • Where possible, reduce number of needle sticks.

Lab Considerations:

  • Hemolysis is common in pediatric samples, especially when sent to central labs.
  • Local labs are better equipped to handle small volumes.

Operational Strategy:

  • Develop a priority list of tests for sites.
  • Avoid overburdening children and families with excessive blood draws.
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