If one of the parties does not act as a promoter, it should have the possibility to withdraw it and to intervene or induce a third party. The principal investigator, and the institution in particular, may find this attitude unacceptable, but it is preferable to explain that the principal investigator and the institution cannot assign or transfer the agreement without the permission of the proponent unless it is economically viable to abandon this point. If there is an agreement on a clinical trial, this agreement is part of the main presentation of the research dossier to the review committee (accredited MREC or CCMO). The research sponsor may first submit an unsigned version. The submitted clinical trial agreement must include a reference and version number. Discusses the overall purpose of a CTA, the roles and responsibilities of the parties to the CTA, and how the CTA fits into the research enterprise. It also compares and compares clinical trials with drugs, biologics and devices from CTA`s perspective. If the sponsor has submitted an unsigned version, the sponsor must submit a signed clinical trial agreement to the trial committee for the initial application prior to the start of the study. In the attached cover letter, you must indicate whether the provisions assessed by the review committee have been modified in the signed research contract. This is based on the principle that the signed version must be the same as that approved by the Board of Revisors. An amendment to the two aspects of the clinical trial agreement reviewed by the Review Committee – the criteria for early completion and publication of study results – is considered a material change and will be re-evaluated by the Review Committee. You must clearly indicate in the cover letter the changes that have been made.

Again, upon receipt of approval of the amendment, a signed clinical trial agreement must be submitted to the Review Committee for information. For more information, see the initial assessment procedure described above. Adequate version control and accurate description of changes to individual versions are of the utmost importance in order to reach early agreement from the Review Committee. Without clinical trials, pharmaceutical companies (sponsors) would not be able to bring drugs to market to save lives and continue to gain concrete knowledge about drugs. •The reasons and facilities of the clinical trial. •Adherence to protocol. • Ensure that the principal investigator and all other staff conduct the study in accordance with applicable legislation, industry best practices, ethics committee accreditation, standard operating procedures and monitoring protocols. • Review of academic and professional qualifications, experience and training of IP and research staff. When negotiating the clinical trial agreement, the parties should also consider the rights available to the sponsor in the event that the PI can no longer act as a RESEARCHER, .B. if the establishment obtains prior written approval from the sponsor for a replacement PI.

When reviewing the Clinical Trial Agreement, an accredited Medical Research Ethics Board (MREC) and the CCMO will follow the CCMO`s guidelines on the evaluation of clinical trial agreements. The Directive applies to research falling within the scope of WMO and for which there is a written agreement between the parties involved in the funding, establishment and implementation of the research. The sponsor must be satisfied that the protocol, research team and research environment have passed scientific quality assurance and that the study has been approved by the relevant regulatory authority and ethics committees prior to initiation. Last but not least, there is the transfer of obligations in clinical trials. To prepare the clinical trial agreement, you can use the models written by a collaboration of parties gathered within the Dutch Foundation for Clinical Research (DCRF). Two models are available: one for industry-sponsored research and one for investigator-initiated research. It is attended by the best clinical training hospitals (STZ), the Dutch Association of Teaching Hospitals (NFU), the Association of Innovative Medicines, the Foundation of the Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital (NKI/ AvL) and the Association of Contract Research Institutes in the Netherlands (ACRON). If there is no clinical trial agreement, this must be indicated in the cover letter. In the absence of such a statement, the jury assumes that an agreement on clinical trials is part of the research dossier. If the clinical trial agreement is not in place, the review committee considers the research record to be incomplete. TASKS OF THE PI – The main task of the NP is: • Monitor the clinical trial and ensure the well-being of the subjects of the clinical trial. •Medical support for subjects.

• Obtain the consent of the subjects, the approvals of the ethics committee and all other approvals necessary to fulfill their obligations. In the case of multi-centre research, clinical trial agreements require at least one clinical trial agreement for the review of the research dossier. This is the agreement on reference clinical studies. For the other Dutch centres, a written statement from the sponsor is sufficient. The opinion should indicate that the clinical trial agreements for the other centres are similar to the agreement on reference clinical studies with regard to the two aspects examined by the Review Committee. If such a statement is not included, clinical trial agreements for all participating centres must be submitted. The review of the clinical trial agreement is limited to the following two aspects based on the CCMO`s Clinical Trial Evaluation Agreements Directive: Obligations of the Clinical Research Organization (CRO) – Managing a clinical trial is an incredibly time-consuming and resource-intensive activity that many sponsors outsource to a CRO, but the ultimate responsibility for the quality and integrity of the study data remains with the sponsor. The International Conference on Harmonization Guidelines for Good Clinical Practice recommends that all examination-related tasks and functions assigned and performed by the CRO be defined in writing. Tasks that have not been assigned will remain the responsibility of the proponent. In addition, principal investigators may be involved in competing clinical trials at the same time, which could lead to a conflict of interest. If it is a problem, the proponent should have a requirement in the contract that prevents it.

The list of provisions is intended to be a high-level guide only and is not intended to be exhaustive and certainly does not cover all the provisions of a clinical trial agreement. The transfer of rights and obligations is most often dealt with in the assignment provision of the contract. Since the sponsor is ultimately responsible for the study, no party (CRO, RESEARCHER and institution) should be able to transfer its obligations without the explicit consent of the sponsor. If it has been determined that the principal investigator or department wishes to participate, the principal investigator or officer must submit the contract to negotiate the legal terms of the agreement. The CCMO considers that the rapid completion of the study clauses and the publication in these templates are in accordance with the CCMO Directive on the Evaluation of Clinical Trial Agreements. *Note: If the agreement refers to a protocol drafted by UTHealth faculty or a collaboration between a UTHealth faculty member and an industry sponsor, a sponsored research agreement is required. For more information, see Clinical trials – Initiated IP. If you submit a site suitability statement (Verklaring Geschiktheid Onderzoeksinstelling, VGO) as a statement of local feasibility for the study, you must also submit a clinical trial agreement using the new local feasibility procedure.

A Clinical Trial Agreement (CTA) is an agreement between UTHealth and an industry sponsor (typically a pharmaceutical or device company) to conduct a clinical trial in which the protocol is written and provided by the industry sponsor. Clinical trial agreements are detailed to capture the commercial, ethical and financial obligations of the sponsor, institution and principal investigator (physician/principal investigator conducting the clinical trial). Given the details, experienced and informed negotiations are essential for all parties to reach a consensus and save time, money and resources. .