2. Clinical trial capacity building to address
multidrug-resistant tuberculosis: challenges
and the way forward

3. Challenges and efforts in strengthening site
pharmacies and pharmacists in the STREAM Trial
Jan Komrska and Ishmael Qawiy, Pharmacists, Vital Strategies, USA

4. Good Clinical Practice
Trial drugs can only be provided to eligible patients
All subjects are provided information on how to properly use trial drugs

5. Good Clinical Practice Requirements
Facility
Processes
Staff

6. Facility Access control to trial drugs
Manufacturer recommended storage conditions
Sufficient space

7. Processes Standard Operating Procedures (SOPs)
Documentation (packing lists, donation
records, destruction records)
Dispensing records (stock cards, prescriptions)

8. Staff Qualification by education, training and experience
Pharmacy staff: Pharmacists, Pharmacy technicians, Pharmacy assistants, Field workers
On-line GCP course for pharmacy staff
Licensing requirements/Continuous education

9. Challenges
Pharmacists are not dispensing medicines directly to the patients
Infrastructure requires investment to meet the requirements
Installing air-conditioning system does not automatically prevent temperature excursions
Inadequate storage conditions for trial drugs outside pharmacies
SOPs are not in place or do not reflect actual workflows
Management of Pharmacy Site File
Documenting GMP status of trial drug manufacturers

10. Other challenges Language barriers Time zone difference
Geographical distance
Visa requirements

11. Thank you!