Challenges in the implementation of guidelines

 PHARM D 

V YEAR NOTES

CLINICAL RESEARCH

2. Clinical development of drug: 

Challenges in the implementation of guidelines

Pharm D notes

Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.

Some of the challenges in the implementation of GCP guidelines are as follows:

1. Professional training on GCP

2. Infrastructure

3. Regulatory environment

4. IRB/IEC/ERB

5. ICD Administration

6. Safety reporting

7. Investigational product

8. Record keeping/source document(s)

9. Grants and payments

10. Trial report/publication.

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Challenges in the Implementation of Guidelines