GCP case studies-1
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- Oh God! They have recruited 4 patients in 1 month, and this is just my 2nd visit to site! Let me see what they have managed with source and visit assessments...Raja was on sick leave when these patient's were recruited, and I am left with so much data to review now!.
- Though Dr. Vijay did confirm that his Sub-I will be performing all the tasks that Raja was to do...Let me start reviewing data without wasting much time
- Raja, I've finished review of consent, eligibility, screening baseline and randomisation visits for the 4 patients, I was checking the visit notes, and I see here, that in the OPD notes, the Sub-I has mentioned that patient Medical history reviewed and patient seems eligible. The notes go further to say that patient was consented on 24 Feb 2021.
- Then the next entry is for the day the patient was randomised, i.e. 5th March 2021, where the Sub-I has made an entry that "All blood reports reviewed and patient fits the eligibility criteria per protocol, and checklist is signed"Please share the rest of the documents with me....
- Hi Zoya!I have given you all the documents that were prepared by the Sub I.I was not there during these visits you see....
- What am I to do now!
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