The Sponsor-Investigator or their delegate should engage with the sponsoring institution’s legal department when preparing and negotiating agreements.
For an overview of the process, download BEST PRACTICE WHEN NEGOTIATING A CLINICAL TRIAL AGREEMENT.
Once the Sponsor-Investigator or their delegate has drafted an agreement using the appropriate Agreement template or a third party has provided their draft agreement, all changes and additions to the agreement must be reviewed by the sponsoring institution’s legal department before sending to external parties for signature.
Some considerations on how to manage the review process are:
The Sponsor-Investigator and sponsoring institution should ensure they agree with the responsibilities and obligations of both parties. Particular attention should be given to clauses in the agreement that cover:
To help with obtaining signatures, Medicines Australia has released a position statement endorsing the use of e-signatures on these documents.
File all executed agreements relating to the trial in accordance with your local procedures.
The Sponsor-Investigator should file all executed Clinical Trial Research Agreements (CTRA) within the Site Information File (SIF). This is a subsection of the Trial Master File (TMF) which contains duplicates of site-specific essential documents pertaining to participating sites.
The Sponsor-Investigator should file any Material Transfer Agreements (MTAs), Research Collaborative Agreements (RCAs), Confidentiality Agreements (CDAs) and Service Agreements, in the appropriate section of the TMF.
Participating site Principal Investigators should file all executed agreements in the applicable section of the Investigator Site File.
Both Sponsor-Investigators and participating site Principal Investigators should provide their organisation’s legal office with a copy of all Agreements, including hard copies with wet ink signatures where available.