Where MR-Researchers Should Start: CIP, IB, and CRFs
A short, practical roadmap for preparing the main documents for a MR-trial using non-CE-marked RF-coils and/or RF-pulse sequences for a clinical investigation in the field of MRI/MRS.
The “chicken-and-egg” of CIP and IB
The Investigator’s Brochure (IB) and the Clinical Investigation Plan (CIP) depend on each other. The CIP needs device and risk information from the IB; the IB should reflect the study’s intended use and procedures defined in the CIP. Treat them as parallel, iterative
documents rather than a strict sequence.
Start here (fast path)
- Gather your scientific dossier (often already approved by a funding agency):
objectives, hypotheses, endpoints, target population, device description, and prior evidence. - Draft the CIP (v0.1):
objectives, design, endpoints, visits/procedures, eligibility, statistics, monitoring, and safety reporting. - Assemble the IB (v0.1) in parallel:
device description and specs, pre-clinical testing, prior human data (if any), risk management summary,
anticipated AEs/SADEs, handling and precautions. - Map outcomes to CRFs:
create CRFs/eCRFs only after endpoints and assessments stabilise in the CIP (minimise rework). - Iterate:
update the IB when CIP procedures change; update the CIP when IB risk information or device limits are refined. - Submission bundle:
CIP + IB (and CRFs ready for use), plus essential supporting documents (IFU, risk files, monitoring plan).
What to prepare first (checklist)
- Clear intended purpose/clinical performance for the device (IB/CIP).
- Device description, interfaces, and operating limits relevant to MR safety (IB).
- Risk management summary (heating, PNS, acoustic noise, implants, misuse) with controls (IB/CIP).
- Study design, endpoints, statistical plan, and monitoring approach (CIP).
- CRF field list aligned to endpoints and safety reporting requirements (CRFs).
Common pitfalls to avoid
- Writing the CRFs before endpoints are final—leads to repeated redesign and validation.
- Letting the IB lag behind CIP changes—creates inconsistencies at submission and site start-up.
- Missing MR-specific risks or controls—ensure SAR limits, screening, hearing protection, and device compatibility are explicit.
- Unclear roles for investigators vs. sponsor—state responsibilities and reporting timelines clearly in CIP and IB.
Suggested working order
- Scientific dossier → extract objectives/endpoints and device overview.
- CIP v0.1 ↔ IB v0.1 (iterate together until consistent).
- CRFs aligned to final endpoints and safety data requirements.
- Final consistency check across CIP, IB, CRFs, IFU, and risk documentation.
Quick FAQ
Can I submit while CRFs are still being tweaked?
CRFs should match the final endpoints and procedures. Minor layout refinements are acceptable; avoid changing data fields after submission.
Which document “leads” changes?
Neither. If the device limits or risks change, update the IB first and mirror impacts in the CIP.
If the study design changes, update the CIP and reflect any procedural safety implications in the IB.
What if I only have a grant proposal?
Use it as your seed. Convert aims/endpoints into CIP sections and extract device, evidence, and risk content to start the IB.