Study-activation checklist · free tool

Clinical trial agreements in South Africa: what holds up study activation

Study activation slips when responsibility for regulatory and ethics gating, budget, indemnity, data and injury cover is left unresolved in the agreement. Work through the 17 questions below before the site is due to open.

0 of 17 reviewed

01 · Parties & contracting structure

Are all parties correctly identified — sponsor, CRO, institution, site and principal investigator — and is the contracting structure (sponsor-site, sponsor-institution or tripartite) settled?Is it clear which entity contracts in South Africa, and does it have authority to bind the site and the institution?

02 · Regulatory & ethics gating

Is SAHPRA authorisation for the trial in place or scheduled, and does the agreement track the actual regulatory pathway?Is Research Ethics Committee approval secured, and are the agreement's obligations consistent with the approved protocol?Is the trial registered as required on the national clinical-trials registry?

03 · Budget & payment

Is the budget schedule agreed, with per-subject and milestone payments, pass-through costs and holdback defined?Are payment timing, currency, VAT and invoicing mechanics clear?Who bears the cost of screen failures, protocol deviations and over-enrolment?

04 · Indemnity, insurance & subject injury

Does the sponsor indemnity cover the site, the institution and the investigator, and does it match the protocol and local requirements?Is clinical-trial insurance in place to the required limits, and is trial-subject injury compensation addressed?

05 · Data, samples & IP

Is data ownership, access and the POPIA basis for processing — including cross-border transfer — defined?Are the use, storage, export and future use of biological samples covered by a material-transfer agreement and consent?Who owns arising IP and inventions, and are publication rights, review periods and embargoes agreed?

06 · Conduct, term & termination

Are GCP, protocol-compliance, monitoring and audit rights set out?Are the termination triggers, wind-down obligations and the survival of key clauses (safety, data, indemnity) clear?Is there a mechanism for resolving disputed positions during start-up, so activation is not held hostage?

07 · Timeline

Is the site-activation deadline reflected, and are the critical-path approvals (regulatory, ethics, contract) sequenced against it?

General orientation only — not legal advice, and no attorney-client relationship arises from its use. A specific matter requires a written engagement.