drug regulatory affairs

1. Clinical Research Regulations
PG SEM I (MRA 103T)
Unit 1: Clinical Trial Protocol
Dimple Marathe
Assistant Professor
Sanjivani College of Pharmaceutical Education & Research
Kopargaon

2. Definition
• The protocol must be carefully designed to generate statistically and scientifically sound
answers to the questions that are being asked and meet the objective(s) of the study
• The objective(s) should also justify the risk; that is, the potential benefits (if any) of
participation in the study should outweigh the risks

3. Scientifically Justified
• Research involving humans should be scientifically justified and described in a clear,
detailed protocol
• “The experiment should be such as to yield fruitful results unprocurable by other methods
or means of study, and not random and unnecessary in nature” (The Nuremburg Code)
• “The design and performance of each experimental procedure involving human subjects
should be clearly formulated in an experimental protocol ” (Declaration of Helsinki)

4. Detailed Protocol. .
• A protocol “provides the background, rationale, and objective(s) of a biomedical research
project and describes its design, methodology, and organization, including ethical and
statistical considerations
• Some of these considerations may be provided in other documents referred to in the
protocol” (WHO Operational Guidelines for Ethics Committees that Review Biomedical
Research, Glossary)

5. Detailed Protocol
• General information
• Background information
• Description of the trial objectives and purpose
• Description of the trial design
• Criteria for inclusion, exclusion, and withdrawal of study subjects
• Treatment information
• Methods and timing for assessing, recording and analysing data gathered on the
investigational product

6. Detailed Protocol
• Methods for obtaining safety information, including plans for safety monitoring
• Description of the statistical methods to be employed
• Description of ethical considerations relating to the trial
• A statement related to permitting trial-related monitoring, audits, and inspection by the
sponsor, IEC/IRB, and regulators, including direct access to source data/documents
• Means for obtaining informed consent and communication of information to prospective
subjects

7. References
• https://www.who.int/medicines/areas/quality_safety/safety_efficacy/gcp1.pdf

8. Thank You