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Documents Required In A Clinical Study Add in library

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Describe about the Documents Required in a Clinical Study?



The essential documents needed while performing the investigation on clinical study is not described elaborately by the Federal governing committee. This has quite a few major purposes.

1. Demonstrating the laws with the total requirements to the sponsors and the investigators.

2. Assisting the sponsors, investigators for the successful study of management.

3. Confirming the validity for conducting the clinical investigation and sincerity in data collection.

Documents required before starting a clinical study

While starting the clinical study certain documents are required. That are-

I. Brochures for the investigators- In this documents the current information are present which helps the investigators by providing the data (Wang, 2012).  

II. Signed Amendments and Protocols- These documents are required to be signed by the investigators for the agreement.

III. Information about the subject- Full information about the subject has to be there. Certain measures have to be taken while doing the work.

IV. Financial side of the study- For the study there should be financial consensus between the sponsors and the investigators.

V. Statement on Insurances- There should be insurance for the subjects who are used for the clinical study(Eriksson and Nilsson, 2008).

Documents needed while conducting the clinical study

While commencing the study there are few documents which are needed.

 I. Updating the Brochure for the investigators- The brochure need to be updated for the investigators so that they don’t have any problem in the information.

II. Revisions of the Protocols and Amendments- The protocols and amendments need to be revised time to time. If the revision is not done properly then it will create problem (Twist et al., 2014).

III. Documents need to be dated – The protocols and amendments which are needed and are used on the subjects are needed to be dated. If the documents are dated then it will be easy to understand that which protocol was used on which date.

IV. Notifications are authorized regularly- The laws which are used in the protocols and amendments are need to be checked on a timely basis so that if any of them needs to be changed due to the new changes done by  the government  than that can be done during the time period.

V. New curriculum for the new investigators- If any new investigator join in the middle then for that person new schedules had to be made according  to his work schedule. This goes same for the new sun investigators (Kmietowicz, 2013).


Documents required after completion of the study-

 When the whole study of clinical protocol is done then there are certain documents which are needed to be looked through-

I. Accountability and investigation of the products are done- The documents that are needed for the investigation of the products are to be done. The accountability of those products is also need to be done at the site (Butcher, 2010).  

II. Documenting the products- The products needed for the investigation purpose are required to be documented because the documentation part will be sent to the investigators and the sponsors so that they can keep a tally of those products.

III. Coding list of the subject- The subjects, who are used for the trials are need to be coded so that it can used in the future for references and this lists should be kept totally confidential (Buccini et al., 2010).

IV. Certificates for the Audit- Every year an audit is done on the study report. Those reports are kept safely for future use and those reports might be required by the government for any compliance purpose.

V. Treatment for decoding and allocating the documents- The documents which are sent to the sponsors might be required for decoding them and for that they are again sent to the sponsors for allocating and decoding those documents.

VI. Final report sent to the investigators and also to the institution- The final report need to be sent to the investigators and also to the institution, for whom the protocol is made so that they can apply in their system.

VII. Report of the Clinical study- The documents of the final report need to be finalized and to be sent for interpretation so that it can be used (Sato et al., 2014).


In a gist it can be said that the whole process of documenting the report starting from the pre- process till the post process is a long task (Saleh Nazzal, 2014). Before starting the report certain things need to be looked through then while doing the report there is also certain task like updating the brochures etc and finally after completing the work the report need to be documented and then sent (European regulator appeals against order stopping it from releasing clinical study documents, 2013).



Buccini, L., Iverson, D., Caputi, P. and Jones, C. (2010) An Australian Based Study on the Readability of HIV/AIDS and Type 2 Diabetes Clinical Trial Informed Consent Documents Bioethical Inquiry, 7(3), pp.313-319

Butcher, L. (2010) First Published Cost-Effectiveness Study of Evidence-Based Clinical Pathways Documents 35% Lower Costs with No Differences in Survival. Oncology Times, 32(5), pp.23-24

Eriksson, I. and Nilsson, K. (2008) Preconditions needed for establishing a trusting relationship during health counseling - an interview study. Journal of Clinical Nursing, 17(17), pp.2352-2359

European regulator appeals against order stopping it from releasing clinical study documents. (2013).BMJ, 347(jul31 2), pp.f4867-f4867

Kmietowicz, Z. (2013). European regulator is ordered not to release clinical study documents. BMJ, 346(may02 4), pp.f2846-f2846

Saleh Nazzal, M. (2014) Virchow Node and Gastric Cancer Clinical Diagnosis is Still Important. J Clin Case Rep, 04(09)

Sato, K., Watanabe, T., Katsumata, N., Sato, T. and Ohashi, Y (2014) Satisfying the needs of Japanese cancer patients: A comparative study of detailed and standard informed consent documents Clinical Trials, 11(1), pp.86-95.

Twist, E., Lawrence, D., Salsbury, S. and Hawk, C (2014) Do informed consent documents for chiropractic clinical research studies meet readability level recommendations and contain required elements: a descriptive study. Chiropr Man Therap, 22(1), p.40.

Wang, B. (2012). Medical equipment maintenance San Rafael, Calif. (1537 Fourth Street, San Rafael, CA 94901 USA): Morgan & Claypool.

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