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Question:

Describe about the Clinical Study Protocol?
 
 

Answer:

Introduction

Protocol is a type of document where it is described that by what method a clinical trial can be conducted (i.e. the designing, objectives, statistics of the trial) and also assures the well being of the subject in trial and the importance of the collected data (Perche and Torchilin, 2012).

In an Institution for developing and initiating a new clinical trial certain time line is maintained-In the beginning for developing a new clinical trial the institute has to go through certain steps. Before they start the program the institute makes a committee who has to go through a pre-program stage where they has to make the conceptual paper then on that paper the protocol draft is made and the editing and format and reviewing is done by the committee members. This whole process takes a time period of around 8-10 weeks. After that the main program starts where the preparation and reviewing of the protocol is done an then the contingencies facilitation is done. After the whole matter is completed then it goes through a review process which takes few weeks and then after completing the whole process the question answer round is done so that with the whole process there is no confusion later (Iwai et al., 2011).

In clinical Protocols there are certain disadvantages also like drop outs of data. If data are missing it creates a lot of problems for the protocol developers (Abrams et al., 2014). While in the processing of developing the protocol and some data goes missing then there is delay for making the protocol and it might cross the delivery time and can create lot of problems. So the data should be kept secure so that the data does not goes missing and no tampering is done with those data (Eizayaga and Waisse, 2014).

 

Clinical Study Process

Collecting Clinical Study Related information and analyzing the clinical requirements.

Calculating the estimated sample size and developing the designs of the protocol.

Screening the clinical sites of SFDA - approving the facilities and conducting the feasibility analysis.

The clinical Protocols are finalized.

The whole clinical study process is done under a certain process which starts from collecting the data for the study till finalizing the protocol. The clinical study has certain processes or steps which is necessary to cover without that the process will not be complete(Brody, 2012).

In the first step all the data and information are collected and then the analyzing of those data is done to see that those data are at all required or not. Then the clinical requirements are analyzed which are required. Then the data samples are calculated and estimated which are needed for designing and developing the data. For design the protocol data are needed and those data need to be of certain sample sizes which will be a help for developing the protocol(Pagliari and Grimshaw, 2002) .For designing and developing the protocol there are certain expenses which need to be feasible for the institution because this is only the beginning and later there will be many other expenses for this protocol. For preparing the protocol the institution need to get certain approval from certain sites. The facilities which is needed for developing the protocol are need to be approved from the clinical sites and had to keep in mind that they are conducted properly(DIERCKX de CASTERLÉ et al., 2008). After going through all the steps then comes the last step where these protocol has to be finalized. When the making of the protocol is completed and then the review is done and it is seen that there is any error or not and after reviewing the protocol it is brought in front of all. After making it public certain question answer session is done regarding the protocol and the confusion of the public are removed (Gallin and Ognibene, 2012).

Conclusion

In a nutshell it can be said that protocol is a record which is maintained by every organization and like that there is a protocol for the clinical study also. These types of study procedures are recorded and detailed planning is done for conducting the study. These wholly explains the functioning that how the study will be carried out .These types of protocols are maintained in clinical institutions through which everyone has to go through. For making this type of protocols the institution has to go through certain steps. Collection and analyzing of data are done before developing and designing of the protocol after that the feasibility tests are done and at the end the protocol is finalized (Wei, 2012).

 

References

Abrams, J., Mooney, M., Zwiebel, J. and Friedman, S. (2014). Improving the Protocol Implementation Process: The National Cancer Institute's Response. Journal of Clinical Oncology, 32(23), pp.2515-2516.

Brody, T. (2012). Clinical trials. London: Academic.

DIERCKX de CASTERLÉ, B., WILLEMSE, A., VERSCHUEREN, M. and MILISEN, K. (2008). Impact of clinical leadership development on the clinical leader, nursing team and care-giving process: a case study. Journal of Nursing Management, 16(6), pp.753-763.

Eizayaga, J. and Waisse, S. (2014). PH-DA: a protocol for observational real-life study of homeopathic treatment of atopic dermatitis in the outpatient private and institutional setting. Homeopathy, 103(1), p.85.

Gallin, J. and Ognibene, F. (2012). Principles and practice of clinical research. Amsterdam: Elsevier/AP.

Iwai, A., Koga, F., Fujii, Y., Masuda, H., Saito, K., Numao, N., Sakura, M., Kawakami, S. and Kihara, K. (2011). Perioperative Complications of Radical Cystectomy After Induction Chemoradiotherapy in Bladder-sparing Protocol Against Muscle-invasive Bladder Cancer: A Single Institutional Retrospective Comparative Study with Primary Radical Cystectomy. Japanese Journal of Clinical Oncology, 41(12), pp.1373-1379.

Pagliari, C. and Grimshaw, J. (2002). Impact of group structure and process on multidisciplinary evidence-based guideline development: an observational study. Journal of Evaluation in Clinical Practice, 8(2), pp.145-153.

Perche, F. and Torchilin, V. (2012). Abstract B49: Cancer cell spheroids as a model to study sequential chemotherapy protocols. Clinical Cancer Research, 18(10_Supplement), pp.B49-B49.

Wei, Y. (2012). Clinical outcomes research of traditional Chinese medicine——introduce registry intensive hospital monitoring study protocol of traditiona Chinese medicine injection's safety.China Journal of Chinese Materia Medica.

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