Hi Victoria,
As for CV renewal during particular study:
While it is not typically required to update investigator CVs after a study has been initiated, there are certain situations where it might be necessary or beneficial to do so. Here are some key points to consider:
Regulatory Requirements: Regulatory authorities generally do not require investigator CVs to be updated after study initiation unless there are significant changes that could impact the investigator’s ability to conduct the study safely and effectively. However, it is always a good idea to check specific local regulations and guidance.
Changes in Qualifications or Experience: If an investigator gains new, relevant qualifications, training, or experience after the study has started, it may be beneficial to update their CV. This can help demonstrate the investigator’s continued suitability to conduct the study and can be useful for sponsors, ethics committees, and regulatory authorities.
Changes in Study Personnel: If there are changes in study personnel, such as the addition of a new sub-investigator or the replacement of the principal investigator, updated CVs should be provided for these individuals. This is to ensure that their qualifications and experience are appropriately documented.
Sponsor Requirements: Sponsors may have their own internal policies and may request updated CVs from investigators during periodic monitoring activities or if there are significant changes to the study or study personnel.
Inspections and Audits: In the event of an inspection or audit by regulatory authorities or the sponsor, up-to-date CVs may be requested. Having current CVs on file can help demonstrate compliance with regulatory requirements and the investigator’s continued suitability to conduct the study.
Good Documentation Practice: Maintaining up-to-date CVs for investigators and study personnel is part of good documentation practice. This ensures that records are accurate, complete, and current, which is crucial for maintaining the integrity and credibility of the clinical trial.
In summary, while it is not typically required to update investigator CVs after a study has been initiated, there are situations where it may be necessary or beneficial to do so. It is important to maintain good documentation practices and to comply with any specific requests from sponsors, ethics committees, or regulatory authorities. If in doubt, it is always a good idea to consult with the sponsor or the relevant regulatory authority for guidance.