This template belongs to the protocol deviation resolution guide, which covers what to inventory before a research system migration. Fill the form in one call with the quality director, then compare it with the completed Illustrative version below.
The handoff form, field by field
Copy the form. Each field takes a phrase, a number, a year span or "unknown".
| Field | What to write |
|---|---|
| 1. Organization | [CRO, site network, sponsor operations group; therapeutic focus; full-time staff at peak] |
| 2. Business task | Logging, classifying and resolving protocol deviations across studies |
| 3. Record classes | [Which of: deviation entries and their severity, corrective actions, monitor findings, amendment history, analysis-set decisions] |
| 4. Systems | [Where visits are captured; where deviations and corrective actions are tracked; where amendments are filed; where biostatistics keeps its decisions] |
| 5. Coverage | [Years per system; approximate study count; anything older kept outside a system?] |
| 6. Version link | [Is the protocol version stored per deviation, inferred from dates, or unknown?] |
| 7. Record owner | [Usually the quality director] |
| 8. Decision-maker | [CEO, COO or CFO, with counsel] |
| 9. Open question | [One thing nobody can confirm yet] |
| 10. Access event | [System migration, read-only period end or retention date, with its documented source] |
| 11. Rights note | [Sponsor-controlled trial records versus the company's own procedures, training and audits] |
| 12. Not shared | No records, exports, participant IDs, sponsor names or logins |
Field 12 is fixed. Field 6 often decides how useful the history is.
Notes for the fields a quality director hesitates over
3. Record classes. List classes, not documents. "Monitoring visit reports, 2018 onward" is a class. "The report on the week-12 visit at site 14" is a record and stays out.
5. Coverage. Studies and years tell a reviewer more than a deviation count, which varies by therapeutic area and study size. If early studies lived on spreadsheets, say so and mark them "to be confirmed".
6. Version link. Ask directly: when a deviation is logged, is the amendment in force recorded with it? The system map explains why the answer matters, and the worked exception example shows a case that turned on it.
10. Access event. A date with a source, such as a migration plan or the end of a legacy read-only period. Regulatory retention periods are a separate clock: for investigator records, 21 CFR 312.62 sets 2 years after a marketing application is approved for the indication, or 2 years after the investigation is discontinued and FDA is notified if none is approved. The brief records the company's own documented dates; it does not compute regulatory ones.
11. Rights note. One sentence. The who-can-license tree explains why the split between sponsor records and the company's own records shapes everything that follows.
Why a short brief is enough for this record type
A reviewer can infer a lot from two numbers, because deviation handling is written down by design. The FDA draft guidance on protocol deviations, published in December 2024, sets out what counts as an important deviation and who reports what to whom. ICH E3 expects each clinical study report to list important deviations grouped by site and category. A company with eight years of studies is therefore likely to hold graded, dated entries for those years, and the brief does not need to prove it. What the brief cannot let a reviewer infer is the version link and the rights split, which is why fields 6 and 11 exist.
The form completed for a fictional CRO (Illustrative)
Written for this page about a fictional 340-person contract research organization specializing in early-phase work. Every value is invented.
| Field | Illustrative entry |
|---|---|
| 1. Organization | Early-phase contract research organization with two clinical units, 340 full-time staff at peak |
| 2. Business task | Logging, classifying and resolving protocol deviations across multi-site studies |
| 3. Record classes | Deviation entries with severity, corrective actions, monitor findings and amendment history; analysis-set decisions held by sponsors, mostly |
| 4. Systems | Electronic data capture since 2018; a quality management platform since 2016; a shared regulatory drive for amendments |
| 5. Coverage | About eight years and 60 studies; a few legacy studies kept in workbooks |
| 6. Version link | A dropdown field since 2022; before that, amendment numbers typed in comments |
| 7. Record owner | Quality director |
| 8. Decision-maker | CEO, with general counsel reviewing contracts; quality director as sponsor |
| 9. Open question | Will the typed amendment numbers in old comments survive the quality platform upgrade? |
| 10. Access event | Quality platform upgrade scheduled next year, per the signed vendor statement of work |
| 11. Rights note | Study data largely sponsor-controlled; the company's own SOPs, training files and audit reports likely its own |
| 12. Not shared | No records, exports, participant IDs, sponsor names or logins |
Read it as the CEO would. It says what exists, how far back, where the weak link is, who owns it and when access changes, without a single record.
A pre-send check
Before the brief goes anywhere, confirm:
- Every value is a count, a year span, a system type, a role or a documented date.
- No sponsor, study code, site name or participant identifier appears.
- The decision-maker is a person who can sign for the company, not a system administrator.
- The access event cites its source, or says "none known".
- Nothing is attached.
The CRM migration handoff checklist applies the same discipline to another system change, and the CRO retention guide covers a related trigger.
From brief to review
If the CEO agrees to a call, the company applies and SourceX reviews record classes, rights and qualification. SourceX licenses approved business data directly from companies for AI training and evaluation, and manages the agreement, rights review, data preparation, delivery and payout. What stays unknown until that review: which record classes the company controls, what de-identification is needed, whether sponsor consent is required, SourceX's current data needs and any offer. The client opportunity brief generator can turn the form into a short email; other sectors are listed under industries.
The company needs 50+ full-time employees at peak (contractors excluded), a documented operating history, rights to license and an authorized contact. Companies in the U.S., Canada and the EU qualify, as do companies in the UK, Australia, New Zealand, India, Singapore, South Africa, Latin America, the UAE and Saudi Arabia when at least 90% of the data is in English. Partners sign the Channel Partner Agreement before submitting; the first valid introduction within the 90-day window is credited when the company submits a verified application.
Next step
Refer a company. Earn up to $100,000. Default reward: 25% of Actual Supplier Payout, capped at $100,000 cumulatively per referred company. Eligibility and payment conditions apply, and a signed Schedule A or addendum can differ. A lead, meeting or signature alone does not trigger payment.
When the form is complete, field 6 is answered honestly and field 12 holds true, register as a partner, confirm the company on who qualifies and read the program terms before the quality director forwards it.