Implementation
CRF
CRF
The principal investigator of each establishment concerned promises to conduct the clinical trial in conformity with the protocol which has been approved by the Ethic Committee and the competent authority.The principal investigator should not modify any aspect of the protocol without prior written permission from the Sponsor nor without the approval of the proposed modifications by the Ethic Committee and the competent authority.The Principal Investigator is responsible for:Providing the Sponsor with his/her CV as well as that of co-investigators,Ensuring co-investigators and other healthcare professionals should be sufficiently qualified by education, training, and experience to perform their tasks,Identifying members of his/her team participating in the trial and defining their responsibilities,Recruiting patients after receiving the Sponsor’s approval.Each investigator is responsible for:Personally obtaining the informed consent form which has been dated and signed by the participant in the research prior to any specific trial selection procedure,Regularly completing the case report form (CRF) for each patient included in the trial and ensuring that the Clinical Research Assistant (CRA) mandated by the Sponsor has direct access to source documents in order to validate information on the CRF,Dating, correcting, and signing the corrections on the CRF for each patient included in the trial,Accepting regular visits from a CRA and possibly visits from auditors mandated by the Sponsor or inspectors from the regulatory authorities.All documentation concerning the trial (protocol, consent form, case report form, investigator file, etc.), as well as the original documents (laboratory results, imaging studies, medical consultation reports, clinical examination reports, etc.), is considered confidential and will be kept in a safe place. The Principal Investigator will keep data as well as a list of patient-identifying data for at least 15 years after the end of the study, or more if specified by the local regulation.