Updated: Apr 8
Investigator responsibilities were significantly expanded upon in the 2016 E6 R2 GCP updates but how do you ensure your site is compliant? This month, we will focus on Investigator Responsibilities and practical ways you can work towards better compliance.
GCP 4.1.1 The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authority(ies)
Ensure all PI's provide a CV that is updated every year. I recommend using the TransCelerate CV template, available for download in the files section of the Sophie Mepham GCP website or directly from the TransCelerate website. To support busy PIs, keep a calendar or similar file that tracks when PI CV's are due, or pick one date each year that all PIs at your site are asked to send updated CV's to the trials unit/team. Send your PI's their old CV from the previous year at least one month before it expires and ask them if there are any significant changes they want to make/add. Ensure any new trials they are working on have been updated by the research team. Check GCP training dates are current on their CV prior to sending and look to assist PIs in booking/organising GCP training if training dates will expire. To save asking PI's for new CV's each time they start working on a new trial, consider having a CV master folder at your site and keep all original research staff CV's here. There is no regulatory requirement to supply PI CV's to Sponsor/CRO's with wet ink signatures and you will need a policy in place to explain if you choose to not provide every CV with a wet ink signature. An example policy is available for download in the files section
How do you manage this responsibility at your site?
Next blog...4.1.2 Investigator oversight of IP and the IB