Cloudbyz CTFM: Confirm Every Site Agreement Is Executed Before a Site Is Activated

ICH E6(R3) is explicit: before initiating a trial, the investigator or institution should have a documented and dated agreement with the sponsor, and the financial aspects of the trial should be documented in an agreement between them (ICH E6(R3), EMA Step 5). Under section 3.6, agreements with investigators, institutions and service providers should be documented before they become involved in the trial.

In practice, sites are sometimes activated while the clinical trial agreement is still being signed, because everything else is ready and the study is behind. That shortcut carries regulatory, financial and legal risk. A site should not be activated until its agreement is executed, and the system that activates the site should be able to see that.

What regulators expect before a site starts

What can go wrong if you activate first

1. A GCP finding. Starting trial activities before the agreement is dated and signed is a gap against E6(R3), and an inspector can see the dates.

2. Missing financial disclosure. In the US, sponsors must obtain financial information from investigators before they participate, and FDA may refuse to file a marketing application that lacks the required certification or disclosure under 21 CFR Part 54 (21 CFR 54.4).

3. Work without agreed payment. If visits start before the budget is signed, there is no agreed basis for paying for them. Sites carry the cost, and disputes follow.

4. Unclear responsibilities. The agreement sets out who does what, including record retention and access for monitoring and inspection. Without it, those responsibilities are not documented.

5. Indemnity and insurance gaps. Agreements usually define indemnity and confirm insurance cover. Activating before they are signed can leave participants, the site and the sponsor exposed.

Activation checklist

• Clinical trial agreement executed and dated by all parties
• Site budget and payment terms signed as part of the agreement
• Financial disclosure collected from investigators (US studies)
• Ethics and regulatory approvals in place
• Essential documents collected and filed
• Site initiation visit completed
• Activation recorded only after every item above is confirmed

What this means by role

• Clinical operations directors: an activation rule tied to executed agreements protects every study from the same finding.
• CTMs and start-up teams: agreement status is part of the activation checklist, not a separate conversation with contracts.
• Contracts and finance teams: the executed agreement is the basis for every payment that follows.
• QA and compliance directors: agreement and activation dates can be checked against each other at any time.

How Cloudbyz CTFM and CTMS do this

Cloudbyz CTFM and Cloudbyz CTMS are built natively on Salesforce as one platform. CTFM tracks each site agreement from negotiation to execution, including the budget and payment terms it contains, and CTMS manages site start-up and activation. Because they share one data model, the study team can see in CTMS whether a site's agreement is executed before the site is activated, without asking contracts or finance. Once the agreement is executed, its terms drive payments in CTFM from the first visit.