Submitting a Clinical Trial Agreement - CTA

Negotiations about the Clinical Trial Agreement (contract), inclusive the financial agreement for all departments (with the exception of the pharmacy) involved in the performance of the clinical trial CTO participates to are done by the Financial Contractor (FC) CTO, Kattie De Belder, in close consultation with the Principal Investigator.

You only need to contact the FC and the pharmacy directly.

Upon agreement with the pharmacy it is possible to add the pharmacy agreement as an attachement to one global CTA (which in that case also needs to be signed by the pharmacist) or you can choose for a main CTA (for CTO and all other hospital departments, except the pharmacy) and a separate contract with the pharmacy. (please note that payments for the pharmacy need to be done on one account and the payments for CTO and all other departments need to be done on another account).

Useful links:

  • CTO terms and conditions (approved by the legal department of  GZA): Please either incorporate those in the Clinical Trial Agreement or add it as attachment to the Clinical Trial Agreement
  • Clinical Trial Agreement signatures and bank details: reference of parties of the hospital who need to sign the CLTA and our invoice references (also see below)

Documents to provide to the FC:

  • Protocol version, (to be) submitted to the EC
  • Informed consent version, (to be) submitted to the EC
  • Clinical Trial Agreement proposal
  • Financial proposal, incorporated in the Clinical Trial Agreement or seperately + excelversion of the budget (if available)

Information to provide to the FC:

  • Date (planned) EC submission
  • Name Leading EC (LEC)
  • estimated/planned date initiation visit
  • Other participating sites in Belgium
  • Studiestatus worldwide (already ready to enroll in other countries/sites, number of patiënts already included in the trial.....)

A new clincial trial can only be initiated when the Clinical Trial Agreement has been signed by all parties. Therefore the submission of the Clinical Trial Agreement proposal needs to be done well in time (sufficient time prior the submission of study documents to the EC).

Please be so kind as to provide the FC the LEC approval as soon as obtained.

Upon agreement on the Clinical Trial Agreement by all parties a number of copies need to be signed by the sponsor/CRO, who then need to be sent to the FC, who will take care for signatures by CTO/GZA.

What to do in case of an amendment to the protocol, IC, Clinical Trial Agreement?

In case of an amendement to the protocol and/or the informed consent with financial implications, please be so kind as in any case to provide the protocol amendement, the updated informed consent (IC) and the CTA-amendement proposal as well as the (planned) date of EC submission to the FC. Please make sure all documents are “track changes” version and/or provide a clear summary of all changes. By preference this should be done in time before (at the latest at the same time) as the submission to the EC. As soon as the LEC approval is available please do provide it to the FC.