Posted: July 24th, 2021

HUBS2408 Clinical Research Design | Clinical Protocol Development


A medical protocol is a doc that illustrates how a medical trial may be carried out. It incorporates the background, rationale, design, purpose, methodology, selection and the exclusion requirements, analysis of the efficacy, analysis of safety, antagonistic events, discontinuation of the study, statistical points, prime quality administration and assurance, Ethical approval, data coping with and report defending, publication protection, mission timeframe, references, Appendices (1).


Targets of the protocol

The aim is to spice up the evaluation question and clarify the importance of the question, purchase the current knowledge and overview the findings of the alternative researchers who've researched on the related matter, formulation of the hypothesis and targets, buying ethical approval from registered organizations, to recommend a great method required for explaining the question for the achievement of the goal (2).

Protocol writing permits a researcher to critically have a look at and take into account the current obtainable works on a particular matter, design and overview the levels of the mission and ultimately helps all via the conduction of the evaluation work (three).  

Title of the study:

It should be transient, right and concise (three).The title should make the aim of the mission clear, convey the exact motive of the evaluation, mentioning the primary stakeholders.

Endeavor summary:

The summary of the mission should be distinct and should add up the entire vital components of the protocol.


The introduction of the subject should be succesful to hyperlink up with the subject in a straight forward technique. Whereas writing a protocol, it is essential to ponder the power of the study.  Every study has its private limitations related to the tactic and subsequently should be clearly talked about. (1). the introduction ought to complete with how the current evaluation would revenue mankind. The literature overview should progress in a logical technique within the path of the intention of the mission matter (2).


The targets of the mission should logically arrive from the literature overview and should be explicitly mentioned. It is important to state the goals that is required to be achieved. The targets should be logical, coherent,     attainable, life like and concise and should   bear in mind native circumstances, phrased to serve the study purpose (2). SMART targets should be adopted whereas writing the mission:

  • Specific
  • Measurable
  • Achievable
  • Associated
  • Time based.

Specific targets

An in depth account of the targets would help within the extraction of explicit targets. Use of too many targets can lead to defective and poor outcomes. Verbs akin to “to verify, to search out out, to calculate, to substantiate and lots of others.” may be utilized.


It is a assertion that is based on the scientific idea, that acknowledges the connection between two or additional variables which may be assessable (6). It is always constructed considering the evaluation question made. Types of hypothesis assertion:-

Null hypothesis: This consists of an announcement the place there's no affiliation between the variables (H0 or HN). H0 states in contradiction to what the researcher wants (6). The last word outcomes will ultimately decide whether or not or not the null hypothesis must be accepted or rejected in assist of an alternate hypothesis.

Alternate hypothesis: The assertion proposes a attainable finish outcome that researchers can anticipate. The hypothesis is generated from the sooner carried out researches that had displayed an apparent distinction between the groups (6). Alternate hypothesis primarily acknowledged when the null hypothesis is rejected.

As an illustration:

Evaluation question:

Does low cost of stress among the many many nurses helps to reduce treatment errors?

Null hypothesis: Low cost of stress among the many many nurses do not reduce treatment errors.

Alternate hypothesis: Low cost of stress among the many many nurses helps to reduce treatment errors.

The difficulty assertion should be succesful to current a summary of the aim of the mission.

  • What exactly can we have to study?
  • Was the study worth conducting?
  • How will the medical study serve the priorities of the nation?
  • What knowledge may very well be obtained from the study?
  • Is there any closing purpose of the information obtained?
  • How will the findings be disseminated?
  • Who could be the beneficiaries of the study?

Methods and provides

 A medical protocol should be succesful to offer an in depth rationalization of the study design, procedures and techniques for attaining the targets. It often defines the variables. It moreover validates the methods for assessing the variables. It gives an account of the proposed methodology of the information assortment and processing (5). It is the methodology portion of a protocol that decides whether or not or not a hypothesis may be accepted or rejected. The methodology could be subdivided in to following headings.

  1. Analysis design: A study design is the plan of the researcher for purchasing the reply to the hypothesis that is being examined (5).
  2. Analysis inhabitants: It describes about the entire factors of the selection course of.
  3. Sample dimension: The sample dimension should be taken appropriately for economical and ethical causes. Each diploma of the recruitment should be talked about as per the selection requirements (6).
  4. Proposed intervention: this entails recording of the entire actions in order of the prevalence. As an illustration whereas mentioning in regards to the treatment, every the mannequin and the scientific names should be talked about.
  5. Data assortment method : Appropriate data assortment devices should be used akin to retrospective data, questionnaires, laboratory verify opinions, medical examinations, tolls for data assortment (2).

Data Analysis

This portion must be accomplished beneath the steering of a  statistician. Which statistical exams should be used should be talked about appropriately. The variables that has been analyzed throughout the case study and the statistical analysis that must be carried out for measuring the top outcome should be talked about (5).

Strengths and limitations

Strengths and limitations: a paper can have many flaws, akin to weak study design, faulty sample dimension and targets (7). Limitations are the influences that may not be managed by the researcher that areas restrictions on the methodology and the conclusions (6).

Ethical approval

Researchers should bear in mind the subsequent elements sooner than the conduction of the study:

  • The benefits and the risks of the members
  • The members or the subjects should be educated about particulars of the study.
  • Educated consent sort should be signed by the members, containing an in depth particulars in regards to the study, justifications, risks involved, privateness and confidentiality (1). Confidentiality should be maintained whereas the preservation of the affected particular person data.

Budgeting system:

The worth vary requirements should be highlighted exhibiting the head good spending for the transportation, manpower, laboratory exams, gadgets, and costs of drugs. The estimation of the value vary should be related to the appendices. Worth for each of the devices should be justified (1).

That is doubtless one of the crucial very important part of writing a medical protocol. It is the method whereby  the data taken from the alternative particular person’s work, are recognised. Failure to reference a particular thought used throughout the writing can lead to plagiarism factors and could be considered authorized movement and subsequently referencing is such an very important problem in medical protocol enchancment (1).


Primarily essentially the most troublesome step throughout the conduction of a evaluation mission is to prepare a protocol that is transient and however inclusive and clearly gives the summary of the mission. Sooner than the writing of the protocol it is essential to acknowledge the steps throughout the enchancment of a evaluation protocol for buying reliable outcomes. A poorly prepared medical study protocol would scale back the prospect of selling the ideas to the reviewer of the granting group.


  1. Al-JunDi A, SAkkA S. Protocol writing in medical evaluation. Journal of medical and diagnostic evaluation: JCDR. 2016 Nov;10(11):ZE10.
  2. O'Brien Okay, Wright J. The best way to put in writing a protocol. Journal of orthodontics. 2002 Mar 1;29(1):58-61.
  3. Toy A, Eaton KA, Santini A. An Introduction to Evaluation for Main Dental Care Clinicians Half 2: Stage 4. Planning the Analysis. Main Dental Care (UK). 2011 Jan 10;18(1):36.
  4. Rosenthal R, Schäfer J, Briel M, Bucher HC, Oertli D, Dell-Kuster S. The best way to put in writing a surgical medical evaluation protocol:
    literature overview and wise data. The American Journal of Surgical process. 2014 Feb 1;207(2):299-312.
  5. Woodward M. Epidemiology: study design and data analysis. CRC press; 2013 Dec 19.
  6. Toledo-Pereyra LH. Evaluation design. Journal of Investigative Surgical process. 2012 Sep 25;25(5):279-80.
  7. Pan American Effectively being Group. Suggestions for writing a evaluation protocol, 2014. On the market from:

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