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monitor checklist: (with regard to the ct supplies)

i. prestudy visit: yes no


na
1. has the investigator been given a copy of ib and its contents and
has the same been discussed with him and his team?
2. has instructions for handling ip and trial related materials been
given and communicated to the study team?
3. has the ct supplies been ordered?

4. has the randomization code been provided to the f & d and


manufacturer, of ct supplies- a copy to the investigator and to
the study site pharmacist- unsealed/sealed?
5. have the following forms been designed and are they ready?
(drug accountability forms, drug destruction forms, drug
discrepancy forms.)
6. have the shipping records for the cts been arranged in order?
(date of delivery, the site where drug is to be delivered, batch no,
expiry date, shipping agency, mode of shipment)
7. have the storage conditions been documented?
(temperature range, humidity, measures against rodents)
8. confirm that the arrival of the cts will coincide with the
initiation (not too early/late).
ii. study initiation: yes no
na

1. have the ct supplies been delivered, and in time?


2. has the protocol been clearly understood by the investigator
and his team, pt. recruitment, randomization ,informed consent?

3. have all the gcp issues been covered?

4. have the details of storage of the medications been discussed?

5. have the issues in shipment and transportation explored in detail


and responsibilities agreed upon?

6. has the preparation of study medication been discussed with


the investigator?

7. has the drug accountability and patient compliance been


explained to the investigator?

8. if any unusual procedures, drug delivery methods involved-


have they been explained, demonstrated and documented?
9. has the investigator and his team understood concerning storage,
accountability and preparation of the ip?

iii. during the study: yes no


na

1. are the investigator and his team, in compliance with the


protocol, the gcp and the regulatory authorities?

2. have the study supplies been stored correctly dispensed and


accounted for?
3. have the calibration certificate been obtained and logbook
being maintained?

4. are their sufficient, unexpired drug supplies at the site?

6. were there any changes w. r. t. pt. compliance/drugs returned/


methodology of treatment? documented?

7. has the investigator file been checked for correct entries?

iv. study termination: yes no


na

1. is the study closure finalized?


if yes; what type of closure?
completion / termination / pre-term completion / hold?
2. ensure that the following have been checked and completed?
- drug accountability form
- drug destruction form
3. have the randomization envelopes been collected?

4. have all the documents at the study site been adequately filled?

5. have the remaining drug supplies been collected/ if destroyed-


have they been documented?

6. have all the storage records been collected?

7. have all the unused documents and forms been collected?

8. have all the materials taken on contract been returned?

9. have all the equipments loaned to the investigator been returned?


10. have all the financial agreements been terminated?
(pharmacy rentals and any overheads)