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Protocol writing

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Noura Attallah

on 21 August 2015

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Transcript of Protocol writing

- It’s a pre-study procedure and should be written
So, Let’s see what the protocol format is.
There are many formats and sections for the protocol and it differs between various study designs.
1-Project title
- It should be descriptive and concise. It may need to be revised after completion of writingthe protocol to refelect more closely the purpose of the study.
2-Project describtion
A -Introduction:
Why should I write a protocol ?

Protocol Writing
By: Noura Attallah

Protocol writing
By: Noura Attallah
-Third year medical student
-Scientific committee member at SRP
-Email: noora.ahmed131373@med.menofia.edu.eg
What is the protocol ?
- A detailed plan of the study idea, objectives, procedures, methods, and outcomes.
1-Essential if the study involves research on human or experimental on animals to get the ethical approval.

2-Necessary guide if a team is working , to force the investigators to stick the plan and clarify their thoughts.

3-research proposal to apply for fund.

4-High quality research, avoid problems and make publishing much easier.
1-Project title
2-Project summary
3-Project describtion including:
*Data mangement & analysis
4-Ethical consideration
5-Financial plan
6-Publication plan
7-Conflict of interest
- The title page include :
1- Names of the investigators ( principle and co-investigators ).
3-Corresponding autho.
4-institution (responsible for the running of the study).
2-Project summary
-It should summarize all elements, so it can stand on it’s own.
-It should mention background about the study topic, aim,methods, interventions, expected outcomes and it may include list of abbreviations used.
-It assembles the abstract of a published paper.

-It should answer the question why & what :
Why this study need to be done?
what will be it’s relevance?
-It’s a brief describtion of the most relevant studies published on the same topic.
- As a literature review with references showing:
1-Intoduction to topic of interest.
2-What is known already.
3- The gab.
4-Aims of the study.
5-The impact of the study ( How the study will add to science, saves money and lives.
- They should be simple, specific not vague, stated in advance not after the research is done.
- Young researchers are advised to resist the desire to put many objectives or over ambitious ones that can’t be achieved by their study.
-They include :
1-Primary objective
Which is the main purpose of the study & should be focused on a clear and specific aim.
it should be fullfilled through the study.

Secondary objectives
which can be more than one it include other aims of the study or expected associations.
-Should be written carefully & in full details.
-It’s the most IMPORTANT part of the study protocol.
-It should discuss:
* Study design
*participants recruitment and study population.
*Sample size.
*observations or interventions used.
* Data management and analysis.
*Study procedures.

Study design
-It should be explained in relation to the study objectives.
-Be careful when choosing the appropriate design, You can’t change it later.

: where the study is going to be carried out in.
Study population
Depending on the type of the study, the following questions should be answered:
1- What are the criteria of inclusion & exclusion?
2-In intervention studies, How will subjects be allocated to the comparison groups?
3-where and how will you recruit them ?
Sample size
-Should provide information & Justification to t sample size.
too large sample size than needed ..why ?
* increase cost, duration than necessary and it’s unethical if it exposes human subjects to any potential risk !
too small sample size than needed also unethical it will expose subjects to danger without enough scientific results that can’t be significant !
: in every 10 persons with HCV, 5 are smokers.
use 1000 subject, then use 9 !
If done, it needs full details & description must be givenof the drugs or devices used.
-For drugs which are available, provide ( Their proprietary names, manufacture, chemical composition, dose and frequencies )

-For drugs in experimental stage, provide ( available pre-clinical investigations in animals- or results from studies already conducted on humans and an approval from the regulatory agency should be obtained before implementation of the study.
-Will the observations be made? How frequently will they be made?
-If there is a questionnaire, This should be in the appendix of the protocol.
-Laboratory, other diagnostic & investigative procedures should be described.

Data management & analysis
-It should provide details on how data will be manged including analysis, monitoring & verification.
-It should provide information on the available computer facility & statistical methods used for data analysis
-Should be clearly provided with privacy and confidentially.
Study procedures
1-Expected outcomes
*Primary and secondary.
2-Data collection:
*What data will be collected?
*How & when ?
*Details on adverse events.
3-Further subject ( Follow up ):
* when & for what?
*How will you follow up ?
*What data is collected at each time point?
4-Study timeline:
*Expected duration of the study & start time.
*Stages such as screening and treatment plan.
6-Withdrawal of patients:
* What conditions that may make them withdraw?
*Risk and benefits.
* How will you deal with withdrawal?
*Limitations of the study & their effects.

Ethical considerations
Why ??
-In all human research whether it’s of a therapeutic or diagnostic nature, it should be obtained. Even the observational studies should be considered for the individual privacy.

- All the protocols on human studies should have ethical consideration section with two things:
1- A written approval of the appropriate ethics review committee.
2- A written form of informed consent.
-Simply getting an ethical approval isn’t enough.
-consent should be ( In mother language - with statements to describe the nature and purpose of the study - medical terminology should be avoided - any benefits or adverse effects - psycological or social risk if any -mention that the subject has the right to withdraw anytime ).

Financial plan
-Souce of fund : either public or private organizations.
* Public as governmental organizations ( National research councils, institutions & Universities ).
*Inter- governmental organizations (such as WHO that supports researches through funding as well as technical support)
* Private as Non-profit & non-governmental organizations ( Wlcome trust organization in UK )

BUT will my project get funded or not ?!
- Actually fun organizations get hundreds or fund applications every day, So you need to check these points first in your project:
1-Importance & relevance of research question and matching interest of agency.
2-Quality of design.
3-Ability of investigators to carry out the study.
4-capacity of the research facility to do the project.
5-Reasonable time frame.
6-Realistic and justifiable budget within the limitations of the agency.

Publication plan
-What is the appropriate journal to publish your
-List any meetings or conferences where you will be presenting the data & results of your study and your aimed journal.

Conflict of interest
-Clearly mention any consultative relationships that the principle or co-investigators have with any association .

-Mention the references that you used in the background section.

-You can include the ethical approval obtained, the consent ot the questionaire you used if any.
I have some good news
We are done !
Now, Let’s see what the proposal is.
-When applying for a research grant or a study scholarship, you are expected to
hand in a "detailed and precise description of study or research proposal as well as information on any previous study or research projects of particular relevance to a decision of award.

- Applicants write proposals ensure that
*The candidates have done sufficient preliminary reading/research in the area of their interest.
*That they have thought about the issues involved and are able to provide more than a broad description of the topic which they are planning to research.

-There is no fixed formula for writing a proposal. However, your challenge is to convince members of the scientific community that you
*Have identified a scientific problem.
*Have a theoretical background and a methodical approach to solve the problem
within a realistic time frame and at reasonable expenses.

1-Verify that the title, the abstract and the content of your proposal clearly correspond to each other!
2-Maintain a clear structure, an intuitive navigational style throughout the document with headings and summaries, enabling the reader to quickly reference where they are for future commentingز
3-Summarize significant issues and keep a reasonable, clear, declarative writing style (active verbs!) throughout the document;
4-Make sure your proposal does not contain any grammatical, spelling mistakes.
5-Request an experienced academic to proofread your proposal in order to ensure the proposal conforms to institutional and international academic standards.
Writing style

The National Institute of Health (NIH) analyzed the reasons why over 700 research proposal applications were denied. Their findings as to the cause of rejection are worth reviewing:

Nature of the Problem
*It is doubtful that new or useful information will result from the project
*The proposed research is scientifically premature due to the present inadequacy of supporting knowledgeز
Approach to the Problem
*The research plan is nebulous, diffuse and not presented in concrete detail .
*The planned research is not adequately controlled
Greater care in planning is needed
* The research plan has not been carefully designed
*. The proposed methods will not yield accurate results
*The procedures to be used should be spelled out in more detail
*A more thorough statistical treatment is needed
The proposed tests require more individual subjects than the number given
*Competence of the Investigators
*The applicants need to acquire greater familiarity with the pertinent literature
*The problems to be investigated are more complex than the applicants realize
The applicants propose to enter an area of research for which they are not adequately trained
*The principal investigator intends to give actual responsibility for the direction of a complex project to an inexperienced co-investigator
*The reviewers do not have sufficient confidence in the applicants to approve the present application, largely based on the past efforts of the applicants
*Conditions of the Research Environment
*The investigators will be required to devote too much time to teaching or other non-research duties
Common rejection reasons
Let’s have a break for 10 minutes ONLY !
Pray, eat, drink or talk :)
-But it’s format is similar to that of the protocol:
1-Title Page
2-bstract/summary statement of the research project
3-Literature review( Demonstrate that you are fully conversant with the ideas you are dealing with.
4-Objective of the research project.
5-Outline the project ( Describe the intended methods of data gathering, the controls you will introduce, the statistical methods to be used, the type of literature or documentary analysis to be followed )
6-Timetable, Develop a time table (if possible in table form), indicating the sequence of research phases and the time that you will probably need for each phase.
7-Selective research bibliography: List academic works mentioned in your research outline as well as other important works to which you will refer during your research
8-Attachments (List other documents attached to your proposal, References, CV, etc. )
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