Review a clinical trial research agreement against the standard form
Key facts
- Human involvement
- YellowClose supervision
- How AI is used
- Identify which standard template the sponsor has used (Medicines Australia standard form, contract research organisation as local sponsor, collaborative research group, Phase 4, or the medical device equivalent), compare the draft clause by clause against the unaltered template, and build a deviations schedule quoting each change with a proposed response from the institution's negotiating positions.
- What the lawyer must review
- Decide which deviations the institution can accept, particularly on indemnity, insurance, publication, intellectual property and budget terms, settle the responses and approve the schedule before it goes back to the sponsor.
- Written for / version
- US
Open a jurisdiction version of this task to see which instruments apply: US
Who does what
| Role | What they do |
|---|---|
| Assistance | Identify which standard template the sponsor has used (Medicines Australia standard form, contract research organisation as local sponsor, collaborative research group, Phase 4, or the medical device equivalent), compare the draft clause by clause against the unaltered template, and build a deviations schedule quoting each change with a proposed response from the institution's negotiating positions. |
| Lawyer | Set the scope, supervise the work closely, verify every part relied on, resolve omissions and exceptions, and approve the exact output. |
Checklist
- Confirm the instructions, the jurisdiction and the complete relevant material before starting.
- Confirm the right template and version for the trial type before comparing.
- Check each quoted deviation against the sponsor's draft.
- Confirm the indemnity and insurance terms are checked against the institution's requirements, not only the template.
- Check the output against the source documents named in it before it is relied on.
Sources
These are suggested working checks. Confirm the required checking with the responsible lawyer before work starts; the checking approach does not establish permission to use AI.