STUDY DRUG ACCOUNTABILITY

GCP WORKSHOP 2017

Mariani Che Dollah is enrolled in a clinical trial for her hypertension. She was given 2 types of IMP which are ABC 400mg and DEF 200mg. She needs to take one pill each every day. Each bottle contains 28 pills during dispensing. Total number of ABC and DEF pills dispensed to her were 84 pills, respectively. Bottle number 1 were dispensed on 26 January 2017. Bottle number 2 were dispensed on 22 February 2017. Bottle number 3 were dispensed on 22 March 2017. According to protocol, she should complete the treatment after 12 weeks of enrolment. However, on 29 March 2017, she withdrawn from the study due to her inability to comply with the study protocol. Site staff asked her to return all the IMP to check the accountability of study medication.

As the delegated site staff for the study, please complete the Study Drug Accountability Log.

Instructions for CRF Completion

  1. Ensure that all fields are completed.

-Where information is Not Known write NK in the relevant box(es).

-Where information is not applicable write NA in the relevant box(es).

  1. Complete all dates as day, month, year i.e 13/NOV/2015. Partial dates should be recorded as NK/NOV/2015
  1. If there is a mistake:

-Do not use correction fluid

-Draw a single line through the item (the original entry should be able to be read)

-Write the correct entry on an appropriate blank space near the original data.

-Write your initials and the date of correction.

PROTOCOL: OPAL-PAN-ABC/DEF-00156

PRINCIPLE INVESTIGATOR: DR SALMAN AKHLAKEN

SITE CODE: 061

SUBJECT ID: 061-001

INITIAL: MCD

STUDY DRUG ACCOUNTABILITY LOG
PROTOCOL NUMBER:
PRINCIPLE INVESTIGATOR:
SITE NUMBER: / IMP NAME:
PATIENT NUMBER: / PATIENTS INITIALS:
Batch Number / Kit Number / Expiry Date / Date Dispensed / No of Tablets Returned / Checked by / Comments
STUDY DRUG ACCOUNTABILITY LOG
PROTOCOL NUMBER:
PRINCIPLE INVESTIGATOR:
SITE NUMBER: / IMP NAME:
PATIENT NUMBER: / PATIENTS INITIALS:
Batch Number / Kit Number / Expiry Date / Date Dispensed / No of Tablets Returned / Checked by / Comments

QUESTIONS:

  1. What should investigator do when subject missed IP dose?
  1. Premature discontinuation of investigational product.
  2. Continue investigational product.
  3. Inform sponsor and refer to study protocol and Investigational Brochure.
  1. Who is responsible for study drug accountability?
  1. Sponsor
  2. Primary Investigator
  3. Pharmacist
  4. Monitor
  5. Study Coordinator
  1. IP storage
  1. In restricted access (True/False)
  2. In locked location(True/False)
  3. Kept together with other IP/medications(True/False)
  1. From the study drug accountability above, is there any discrepancies observed? If yes, why? If no, please explain.
  1. What action should be taken if you found any broken tablets before dispensing the IMP to subject?
  1. Replace the broken tablet with another tablet from new bottle.
  2. Continue dispensing the investigational product to the subject.
  3. Inform sponsor immediately and quarantine the whole bottle before dispensing a new bottle of IMP.
  4. Throw away the whole bottle of IMP