This Challenge is based on the following scenario which has previously been reviewed and commented on in My GCP Zone. Please read the scenario before attempting the questions:
CRA Prioritising Exercise
You are the CRA on a global phase II clinical trial. You are CRA for all 4 sites in a single country and have just started on the project, taking over from a previous CRA who has just left the company. Prior to performing your first monitoring visits for the trial you review the Sponsor TMF for your country and notice the following:
Site 1 - there is no documented evidence that there has been an ethics committee approval for the site to perform the study. The site is actively enrolling and randomising patients into the trial.
Site 2 - there is no site selection visit report and no initiation visit report in the file even though the site has enrolled 14 patients into the trial.
Site 3 - While reviewing a report about data queries provided by Data Management this site appears to have virtually no data queries raised against the data but has the highest number of subjects recruited compared to all other sites
Site 4 - The TMF looks ok for this site although it is evident that there are considerably less screening failures at this site compared to other sites.