Review, Execution and Filing of Agreements
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.
Review of Agreements
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:
- Send a draft of the agreement to the legal representative of your organisation to check the clauses in the agreement are acceptable to all parties. Ask your governance or HREC office if you don’t know who the legal person is in your organisation.
- Ask your organisation’s legal representative how much time they need to review a document and factor that into your planning.
- Collate feedback from all organisations signing the agreement, amend the document and resend to all parties for approval before signing. To facilitate this process, consider reviewing the document in a secure collaborative online space so changes and comments can be seen by all parties.
- Send a final version of the agreement for signature once all parties have agreed to the wording. This will avoid delays in executing the final agreement. Requesting signatures twice from senior/executive people within your organisation because the version they originally signed has changed, is a waste of everyone’s time.
Review of Agreements with Medicinal/Medical Device Product Manufacturer/Suppliers
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:
- Protocol approval – consider if it is appropriate for the manufacturer/supplier to be involved
- Data ownership and rules for sharing data
- Publications and presentation at conferences
- Trial registration
- Only those certified to sign on behalf of the organisation (that is a party to the agreement) can sign the document
- All signatures need to be dated
- The last signature to be added to the document is the date the agreement is considered to be active (the term used is “executed”)
- The researcher or Sponsor-Investigator cannot sign on behalf of the organisation that is conducting the study
- Allow time for the signatories to review the document, make changes and ask questions
To help with obtaining signatures, Medicines Australia has released a position statement endorsing the use of e-signatures on these documents.
File the Executed Agreement
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.