The situation
A sponsor’s clinical trial site agreement, uploaded
A sponsor’s CRO has sent your hospital in Wrocław a 46-page clinical trial agreement for a phase III oncology study, with a near-identical version going to a partner site in Olomouc. The site budget is attached, the start date is fixed, and the principal investigator asks every day whether legal has signed.
The template is the sponsor’s, written for many countries at once. The hours go on the clauses that the Regulation and national law decide for you: insurance and compensation, data protection roles, publication, payments to investigators and what happens if the trial stops early. Each has to be checked against two countries’ rules.
What the research has to settle
The rules behind the answer
- The Regulation governs the trial, not the contract
- The Clinical Trials Regulation sets the rules for authorising and conducting trials in the EU, and all ongoing trials have been under it since the transition ended in January 2025. Most contractual terms between sponsor and site are left to national law.
- Compensation for damage is mandatory
- Member states must ensure a system for compensating trial subjects for damage, such as insurance or an indemnity. The agreement’s liability and insurance clauses have to fit the arrangements Poland and the Czech Republic each set.
- Results must be publishable
- The sponsor must submit a summary of the results to the EU database, generally within one year of the end of the trial. A confidentiality or publication clause should not stand in the way of that, or of the publication rights the parties agree for the investigators.
- Data protection roles need stating
- Sponsor and site both process trial subjects’ personal data. The EDPB has addressed how the Regulation and the GDPR interact, including the legal bases for trial data. The agreement should allocate roles and responsibilities to match.
How it runs in azta
From the question to the document
The question, as you would type it
Attached is a sponsor’s site agreement for a phase III trial at our hospital in Wrocław. Check the insurance, indemnity, data protection and publication clauses against the Clinical Trials Regulation and Polish law, and list what we should change before signing.
You start with
A sponsor’s clinical trial site agreement, uploaded
- 01
Upload the agreement and the budget
Add the agreement, the budget and the protocol synopsis. azta reads them and refers back to the clause it relied on.
File upload· Pro - 02
Check the clauses that law decides
Ask about insurance, compensation, data protection, publication and payments. azta cites the Regulation, the Polish and Czech legislation and the EDPB material.
Cited research· Free - 03
Draft the markup memo
Ask for a memo listing each clause to change, the reason and proposed wording. Edit it in Canvas and translate passages for the CRO.
Canvas · Ask azta· Pro You send
A markup memo listing the clauses to change, the reasons and proposed wording
What you get
A markup memo listing the clauses to change, the reasons and proposed wording
Markup memo · draft
Clinical trial agreement, oncology phase III: clauses to change
Clause 11, indemnity and insurance. The sponsor’s indemnity is limited to claims arising from the protocol and excludes the site’s acts in following the sponsor’s instructions. We propose extending it to those acts and attaching the insurance confirmation that meets the national requirements cited in the annex.
Clause 14, data protection. The draft describes the hospital as the sponsor’s processor for all trial data. That does not reflect the hospital’s own obligations for medical records. We propose a role allocation per category of data, consistent with the EDPB’s view of how the Regulation and the GDPR interact.
Clause 17, publication. The draft lets the sponsor delay any publication indefinitely. We propose a fixed review period and a statement that the sponsor’s duty to post the results summary in the EU database is unaffected.
Outcomes on your numbers
What azta is worth on this task
Pro pays for itself after
15 minutes a month
At €110 an hour, that is all the time Pro (€27 a month) has to take off your desk to cover its price.
Example figures. Replace them with your own.
- Hours back a year
- 54
- Capacity at your rate
- €5,940
- More clinical trial agreement reviews a quarter
- 2.1
- Return on Pro
- 18.3×
- Research
- Drafting
- Your review
A scenario you set, not a promise. The hours that come back go to another client, or deeper into this one.
Want these numbers on your team’s real workload?
Book a demoWhat stays with you
- The negotiation with the sponsor and the CRO.
- The hospital’s own insurance position and the budget review.
- Ethics committee and authority correspondence, which follows its own procedure.
Frequently asked questions
- Can azta compare the Polish and Czech versions of the agreement?
- Upload both and ask for the differences. azta refers back to the clauses it relied on in each document.
- Does it cover the national clinical trial laws?
- It holds Polish and Czech legislation alongside the Regulation, with in-force status on each citation. Guidance from the national medicines agencies is not in the corpus.
- Can it mark up the sponsor’s document directly?
- It drafts the memo and the proposed wording in Canvas, with Word export on Pro. The tracked changes in the sponsor’s file stay with you.
