Page 166 - eBook Version 8 Book 1 of 2 JUL 2022
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Regulatory Binder:
1. Whenwasthestudyapproved?
2. Howmanymodificationshavetherebeen?
3. Arethesub-investigator’slistedonthe1572ontheDelegationLog?
4. Whenwasthelastmonitorvisit?
5. Howmanysubjectsareenrolled?
6. Istheconsentformcurrent?
7. DoyouhavecurrentCVsforallofthestudyteamontheDelegationLog? 8. HowdoyoufileanSAE?
9. WhenisthenextContinuingReview?
10.Who is your CRA?
11.How long is the treatment period?
Coordinator Binder:
1. Wheredoyoufindthesubjectbinder?
2. Wheredoyoufindthestudymaterialsforallscheduledprocedures:
SOURCE, Lab Kits, ECG, CDs?
3. DoyouhaveacurrentconsentformandHIPAA?
4. Whatisthenextvisitthesubjecttwillcomplete?
