Clinical Trial Review Process

 

A Principal Investigator (PI) submits a Blue Sheet to the Office of Sponsored Programs through the WVU+kc. A boilerplate of the Sponsor’s Clinical Trial Agreement is attached along with the Sponsor’s contact information.

The agreement is reviewed. Below is outline of a few of the points negotiated through the review process.

  • Protocol Number
    • is the Protocol Number consistent throughout the document?
  • Is the West Virginia University Research Corporation a party to the agreement?
  • Is the compensation for Clinical Trials is based on a per patient amount?
  • Is the Sponsor requiring a Site Agreement with University Health Associates or West Virginia University Hospital?
  • Period of Performance
    • Institution must have the right to terminate the agreement for cause for example; Adverse Event, safety and health of patient’s compromised, material breach by Sponsor, IRB, or FDA approval withdrawn.
  • If PI leaves the Institution, can Institution negotiate for replacement pre-termination?
  • Does the Institution have the right to prorate payment based on the amount of work performed prior to termination?
  • In the event of termination, will the Institution be reimbursed for funds irrevocably committed pre-termination?
  • If Sponsor terminates the agreement for material breach by the Institution, Institution prefers a 30 days written notice of the breach with an opportunity to cure
  • Institution also wants to reserve the right to terminate the agreement without cause.
  • Confidentiality
    • Does the agreement require the Disclosing party to mark confidential information as such?
    • Is the definition of Confidential Information, so broad as to preclude publication rights?
    • Are there exceptions as to what is considered Confidential Information stated in the agreement? Such as:
      • is or later becomes generally available to the public by use, publication or the like, through no fault of the Institution or the Principal Investigator;
      • is obtained from a third party without restriction who had the legal right to disclose the same to the Institution or the Principal Investigator;
      • is already possessed by the Institution or the Principal Investigator, as evidenced by recipient’s written records predating receipt thereof from Sponsor;
      • is independently developed by the Institution and the Principal Investigator without the use or benefit of Confidential Information belonging to Sponsor as evidenced by the Institution’s or the Principal Investigator’s written records; or
      • is required to be disclosed by any law, rule, regulation, subpoena, order, decree, or decision or other process of law.
  • Does the Sponsor require Institution to seek a protective order?
  • Notice of regulatory inspections
    • Is the notice of disclosure of confidential information required by Sponsor before disclosure reasonable?
  • Does Sponsor request the right to respond to regulatory correspondence?
  • Is there a reference to a Nondisclosure Agreement (NDA) \Confidentiality Agreement (CDA)?
    • If so, do we have a copy of the NDA\CDA?
    • Are WVU/WVURC employees required to sign an NDA\CDA?
  • Publications – Institution must have publication rights without the written approval of the Sponsor.
    • The Institution does not grant excessive pre-publication review periods (30 days for review, 60 days for patent protection, and 12 month delay for multi-center publications (if applicable)). Insert standard publication language when needed.
  • Are we allowed to acknowledge the existence of the agreement?
    • If not, are we allowed to use a generic project title?
  • Ownership Rights of Intellectual Property
    • Who owns rights to data, inventions, etc…
  • Does the Institution maintain a right to use data for internal, educational, research, and patient care purposes?
  • Does the Institution have the right to retain copies of the data, or other information resulting from the project for archival purposes?
  • Does the PI/Institution retain the copyright to publications that result from the agreement?
  • Warranties
    • Is there a Disclaimer by Sponsor? If so, has the mitigating language been inserted?
  • Jurisdiction
    • Must be WV, court of competent jurisdiction, or remain silent.
  • Insurance
    • Is our insurance coverage properly state in the agreement? Is a Certificate of Insurance required?
  • Indemnification
    • Institution does not indemnify or hold harmless. We agree to be responsible for intentional or negligent acts or omissions only.
  • Has the Association for the Accreditation of Human Research Protection Programs (AAHRPP) language been added?
  • Has the Protocol been submitted to the IRB for review?
  • Signature Line
    • Correct use of party name throughout?
    • Is the signatory a representative of the party?
    • If not, is there a Letter Of Indemnification in place?

After the agreement is reviewed, exceptions are sent to the Sponsor. Sponsor’s feedback on the exceptions is discussed weekly with the authorized signatory.

Please use the following Clinical Trial Agreement Checklist to assist you in the process:
CTA Award Checklist

Disclaimer:

This information is intended for educational purposes only, and is not intended as legal advice. It does not replace professional judgment.

Each situation is unique, and the associated risk should be assessed according to the individual circumstances.