A sponsor can delegate specific responsibilities to any other individual or organisation that is willing and able to accept them. Any delegation of responsibilities to another party should be formally agreed and documented by the sponsor. Noncompliance with the protocol, SOPs, GCP, and/or applicable regulatory requirement(s) by an investigator/institution, or by member(s) of the sponsor’s staff should lead to prompt action by the sponsor to secure compliance. The sponsor should utilize appropriately qualified individuals to supervise the overall conduct of the trial, to handle the data, to verify the data, to conduct the statistical analyses, and to prepare the trial reports.
- The research proposal respects the dignity, rights, safety and wellbeing of participants.
- Independent scientific peer review has demonstrated the work to be worthwhile, of high scientific value and good value for money
- Participant privacy is protected and any disclosure of a participant’s confidential information is managed appropriately
- Each study should be appropriately managed and monitored according to the risks inherent within the study, and this should be documented. The initial risk assessment should be completed at the protocol development stage.
- The study is managed and conducted according to all relevant local, national and international law and good practice guidance.
- The research proposal or protocol takes into account any relevant systematic reviews, other research evidence and research in progress, to ensure the quality and relevance of the research.
- In the event of an untoward medical occurrence an adequate system for reporting, recording and reviewing must be in place and made clear within the protocol.
- The sponsor should ensure that the investigators, research team and research sites are suitable.
- Indemnity arrangements are in place in the event of harm to a research participant.
- Potential participants should be provided with information in a suitable format which clearly explains what participation in the research would involve. Where consent will be obtained, this information should support any decision-making about taking part.
- The sponsor should approve any modification to the design of studies, and ensure that arrangements are in place to obtain any necessary approvals, and implement necessary changes.
- Study participants, their representative groups and/or the public should be involved, wherever possible, in the design, conduct, analysis and reporting of research.
- Protect the integrity and confidentiality of records and data; and report any failures in these respects or suspected misconduct.
- The study is conducted in accordance with the approved protocol and the terms and conditions of the relevant approvals.
- All projects are subject to internal and external monitoring. Units / institutes should allow access to study team, documents, devices and equipment for monitoring purposes. This should be made clear in participant information sheets.
- Key research records or documents are maintained in a legible condition and can be retrieved promptly. As a minimum these would include the following:
- Protocol and amendments, including management and monitoring plan;
- Participant information sheets and consent forms;
- Submissions to ethics and regulatory authorities, and letters of approvals;
- Study-specific Standard Operating Procedures.
- Ensuring databases are locked prior to analysis;
- Notifying the IEC/IRB and any other relevant approval bodies that the study has finished;
- Ensuring the collected data will be retained for the appropriate period
The sponsor-specific essential documents should be retained until at least 2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2 years have elapsed since the formal discontinuation of clinical development of the investigational product. These documents should be retained for a longer period however if required by the applicable regulatory requirement(s) or if needed by the sponsor.
The sponsor should inform the investigator(s)/institution(s) in writing of the need for record retention and should notify the investigator(s)/institution(s) in writing when the trial related records are no longer needed.The sponsor should ensure that the investigational product(s) (including active comparator(s) and placebo, if applicable) is characterized as appropriate to the stage of development of the product(s), is manufactured in accordance with any applicable GMP, and is coded and labelled in a manner that protects the blinding, if applicable. In addition, the labelling should comply with applicable regulatory requirement(s).