Review Process:
Through on-going review, the draft contract is edited using track changes. Often previous contracts with the sponsor/CRO are used to check precedent.
Where the sponsor’s language/clauses significantly differ from the RID approved CTA template; suggested language is inserted into the draft copy. Often comments are added to explain edits or request additional information from the sponsor/CRO or provide links or reference to supporting documents (i.e., NSHA RID policy, NS Finance Act, etc.)
The Contract Coordinator brings any extraordinary liability issues or requests in the draft contract to the attention of the Investigator and/or related RID/ NS Health (Director, REB Manager, and/or Quality Assurance Manager) and/or Legal Services (Legal Advisor, Claims Officer, Privacy Officer) for advice. The revised draft is sent back to the Sponsor/CRO with supporting documents. The Contracts Team has set a benchmark response time as listed below.
The draft contract is sent back from the sponsor/CRO/Lead Site/External Party with track changes either “accepted” or “rejected” with comments. If our suggested language has been rejected by the Sponsor/CRO, the Contract Coordinator negotiates with the sponsor/CRO via email and/or telephone.
If the sponsor/CRO is unwilling to accept suggested language from RID’s approved Research Study Agreement template the Contract Coordinator may, where appropriate, accept language that falls within the “acceptable” parameters of the Clinical Studies Agreement Best Practices For Agreements with Private Industry Sponsors document prepared by the Council of Academic Hospitals of Ontario (CAHO), as it applies to a particular Study Agreement. For example, the contract requirements of a phase II clinical trial vary from those of a phase IV observational study.
If the sponsor/CRO/Lead Site is still unable to accept the requested changes to the contract, the issue is escalated to the Contracts Manager and Legal Advisor and/or Senior Leadership for final review and resolution.
Response Timelines
Upon receipt of the contracts below, the following are the intended timelines for response from the Contracts Office.
- CDA.NDAs: 3-5 business days
- DTA.MTAs, SAs, and CTA.CSAs: 10-15 business days - this review is specific to the terms of the CTA and may not include the budget.
Please note: Budget review and consideration in consultation with the research team will also take place during this time. Budget response times may exceed 10-15 business days as it is dependent on internal processes, protocol review and study team demand.
