PROTOCOL WRITING IN CLINICAL RESEARCH

PROTOCOL WRITING IN CLINICAL RESEARCH

• Writing a protocol is a extremely burdensome work of a researcher.

• The researcher who writes a protocol which is to be used during the conduct of the clinical research should be a qualified,trained and have a relevant experience in the scientific field.

PROTOCOL

✓ It is a important document which is prepared according to the standard operating procedures,GCP,applicable regulatory requirements.

✓ It describes the every step to be carried out during clinical research and its importance.

PURPOSE OF A PROTOCOL

✓ The main objective of the protocol is to take into consideration of right,safety and well-being of the human subjects.

✓ Protocol states the risk-benefit analysis of clinical study design.

APPROVAL OF A PROTOCOL

 The primary objective of the protocol should statisfy ethical principles of declaration of Helsinki.The protocol should be submitted to the ethics committee(IRB/IEC) to get approval to begin the study.It describes the eligibility criteria of the human subjects participation and their recruitment.

WRITING A PROTOCOL

1)PROTOCOL TITTLE :- Tittle should be relevant,short and clear.The protocol tittle should aim at what the study is about.

2)AIMS & OBJECTIVES :- It should have protocol identification number and date.Name and address of Investigator and sponsor and their signatures.

3)CLINICAL STUDY DESIGN :- Information regarding the investigational product.Blinding of the clinical study(double blind,triple blind).

4)INCLUSION & EXCLUSION CRITERIA :- Inclusion criteria include like acceptance human subjects based on eligibility criteria and exclusion like pregnant cases.

5)ASSESMENTS & METHODOLOGIES :- Assesment include like conducting audit trial at every phase of trial.Methodologies such as treatment studies and observational studies.

6)STATISTICAL ANALYSIS:- Theses include like maintenance of drug accountability forms.Verifying null and alternateive hypothesis.

7)SCHEDULE OF VISITS :-

i. INITIAL VISIT

ii. PERIODIC MONITORING VIST

iii. CLOSE – OUT VISIT

CONCLUSION

The conduct of clinical trial mainly implies on the prepared research protocol it should be precise,understandable,erroe-free.It will clearly distinguish the responsibilities of investigator,sponsor and human subjects.It is used to test the hypothesis of study report.

REFERENCES

1)https://www.ncbi.nlm.gov/pmc/article/PMC5198475/

2)https://www.nuventra.com/resources/blog/best-practices-clinical-study-protocol-writing/

3)https://www.kolabtree.com/blog/how-to-write-a-clinical-trial-protocol/

SIDDAM SRAVANI (B.Pharm)

Clinosol ID :- 019/0121.