Master Agreements
To improve negotiation timelines and to ensure mutually agreeable terms and conditions between and amongst RID and external parties, master agreement templates are negotiated. These master agreements are in force for 2-3 years as negotiated. The parties to the agreement are the external third party and Nova Scotia Health. For each individual study, there is a corresponding statement of work and budget. These are based on an approved template as included as an appendix to the master agreement. These documents are signed by the PI (if not an Nova Scotia Health employee or represented by RID) and sometimes RID. Master agreements are encouraged to limit contract language negotiation and timelines.
We welcome the negotiation of Master Agreements.
Clinical Trial Agreement (CTA)
CTAs are one of several key documents that govern the conduct of clinical trials. They serve as a legally binding contract between a Sponsor, Institution, and Principal Investigator, and outline each party's responsibilities and obligations for the clinical trial. As indicated above, it is a priority to negotiate a Master Clinical Trial Agreement with Sponsors with whom Nova Scotia Health partners. In the absence of a Master Agreement, the terms and conditions proposed and agreeable to Nova Scotia Health can be found in the approved CTA template.
MD Sub-Investigator Attestation
Given the separate legal entity status of appointed physicians at Nova Scotia Health, should the terms and conditions of a CTA include attestation of compliance and understanding from MD Sub-investigators or study personnel, not represented by the Principal Investigator or Nova Scotia Health, a sub-investigator attestation is signed by all such individuals and appended to the CTA.
Non-Disclosure/Confidentiality Agreements (NDA/CDA)
A non-disclosure/confidentiality agreement (NDA/CDA) is reviewed and signed in advance of the Investigator and Research team receiving the study protocol, contract, or budget or continuing a discussion re: partner or collaboration with a third part. These agreements must be reviewed and approved by the Contracts Team. The CDA/NDA should be aligned with the Nova Scotia Health RID Confidentiality Agreement Template.
Data Transfer Agreement (DTA)
If patient data is being collected at NSHA or extracted from existing Research databases and sent outside of NSHA, and there is no existing contract outlining the terms and conditions associated with such collection and/or extraction and transfer, a Data Transfer Agreement (DTA) may be required (may also be referred to as Data Sharing Agreement).
A DTA will include the following terms:
- Specifics re: information being provided (patient data, aggregate data, scans, or images etc.)
- Use of the Information
- Security, Confidentiality, and Protection of Health Information (compliance with applicable privacy laws, secure computer/server requirements, patient consent to share data, policies, and practices re: health information access and handling)
- Financial Arrangements (if applicable)
- Publication of results
Materials Transfer Agreement (MTA)
If biological/patient samples are being sent outside of Nova Scotia Health (including to Dalhousie) for the purposes of a Research project and there is no participating site agreement outlining the terms of sending and receiving these samples, an MTA is required. An MTA template may be provided by the receiving party, or the RID MTA template will be proposed.
An MTA should include the following terms:
- Ethics requirements.
- approval and informed consent from patients for the sample to leave NSHA.
- Sending and receipt of samples
- Payment associated (if applicable)
- Access and ownership of the samples
- Proper storage, safeguarding and disposal
- Confidentiality and Privacy terms protecting any information associated with the samples
- Approved use of samples – research, analysis, biobanking, etc.
- Publication terms and data access
Participating Site Agreements
Supporting Investigator Initiated Research projects is a priority at Nova Scotia Health. These can be led by Nova Scotia Health based researchers or researchers from an external institution/organization. These studies can be funded through a granting agency, foundation, internal funding program or external industry partner. In order to ensure that the roles and responsibilities of all parties involved in the study and corresponding budget and payment terms are outlined and agreed upon by all parties, a Participating Site Agreement is required prior to commencing the study.
