Protocol Template for Basic Research and Non Interventional
Clinical Studies
Protocol Template, Version # …..,
Date: DD/MM/YY
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PREFACE
This Protocol Template is a suggested format for submitting Basic Research and non
interventional clinical proposals sponsored by the “Dasman Diabetes Institute” (DDI). The
purpose of this template is to provide a general format for writing a research proposal.
Investigators are encouraged to utilize this format, and modify as appropriate, when
developing protocols for their studies.
It is important to note that instructions and explanatory statements (highlighted) should
be replaced in the original protocol with appropriate text. Section Headings and subheadings might be added as necessary.
The version number and date appear at the footer of each page. While submitting an
amendment to an approved and “FINAL” protocol, you may incorporate the changes in the
protocol and submit the new version. A summary of the changes is required as well.
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PROTOCOL TITLE
(The title should be brief but informative, sub titles might be used as appropriate)
Primary or Principal Investigator(s)
(Indicate the Primary or Principal Investigator’s name, degree, position and affiliation)
Co-Principal Investigator
(Indicate the name, degree, position and affiliation of Co-Principal Investigator, if any)
Co-Investigator(s)
(List all Co-Investigators with their names, degree, position and affiliations)
SPONSORING AGENCIES
DASMAN DIABETES INSTITUTE
(If the study initiated in another institution, include names of the sponsoring/collaborating
institutions that support the study)
(Any modification to the protocol should be properly justified on a separate sheet or in an
appendix. The exact word, statements, or phrases that are changed and the location of
these changes in the protocol should indicated)
Version # 1, Dated: Day/Month/Year
(Version number, as appears in the footer, needs to be changed with each amendment)
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Contents
1 ABSTRACT OR PRÉCIS ............................................................................................................................................... 2
2 INTRODUCTION (Rationale and Background Information) ........................................................................ 3
2.1
Background Information ....................................................................................................................................... 3
2.2
Study Rationale .......................................................................................................................................................... 3
3 AIMS AND OBJECTIVES.............................................................................................................................................. 4
The aims should specific, clear, concise, and achievable. ........................................................................................... 4
4 EXPERIMENTAL DESIGN, MATERIALS AND METHODS .................................................................................. 5
5 STATISTICAL CONSIDERATIONS ........................................................................................................................... 6
5.1
Statistical Methods ................................................................................................................................................... 6
5.2
Data Collection and Quality Assurance ............................................................................................................ 6
5.2.1 Data Collection Forms ............................................................................................................................ 6
5.2.2 Data Management .................................................................................................................................... 6
5.2.3 Quality Assurance .................................................................................................................................... 6
5.3
Interim Analyses and Stopping Rules: ............................................................................................................. 7
6 ETHICAL CONSIDERATIONS .................................................................................................................................... 8
6.1
Human Subject Involvement ................................................................................................................................ 8
6.2
Informed Consent Forms ....................................................................................................................................... 8
6.3
Participants’ Confidentiality................................................................................................................................. 8
6.4
Study Discontinuation............................................................................................................................................. 9
7 PUBLICATION OF RESEARCH FINDINGS........................................................................................................... 10
8 WORK PLAN (Organization and Management) ............................................................................................. 11
8.1
THE STUDY TEAM ROSTER ............................................................................................................................... 11
8.2
TIME FRAME OF EVENTS ................................................................................................................................... 11
9 THE BUDGET.............................................................................................................................................................. 12
10 CONTINGENCY PLANS .......................................................................................................................................... 13
11 REFERENCES ........................................................................................................................................................... 14
12 SUPPLEMENTS/APPENDICES ............................................................................................................................ 15
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1
ABSTRACT OR PRÉCIS
This section should provide a one-page executive summary of approximately 300- 500
words, divided in 3-4 paragraphs. It should summarize all central elements of the
protocol; for instance, rationale, aims and objectives, study design, experimental
methods, study population, expected outcome, and work plan etc. It should stand on its
own and should not refer the reader to points in the description of the study.
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2
INTRODUCTION (RATIONALE AND BACKGROUND INFORMATION)
As in a scientific paper, the introduction puts the proposal in context. The magnitude
and frequency of the problem, geographical areas, the age and gender of the affected
population, etc should be supported with references from the most relevant current
literature. Recommended length is 2-4 pages, should not exceed 5 pages.
2.1
2.2
Background Information
 To describe the magnitude of the problem, state the available scientific
and medical data from current literature on the Condition or Disease that
is the focus of the study.
 State what has already been accomplished in the field so far. What were
weaknesses in the previous work? Indicate gaps in the field of
investigation, and how would the proposed study bridge those gaps.
 The results of observational studies and early clinical trials that justify
the study, its design, and the intervention groups should be provided.
 Include any data from animal and human studies relevant to mechanism
of action, effect size, and possible effects of the intervention on selected
outcomes.
Study Rationale
 The rationale specifies reasons for conducting the study, i.e. why is the study
worth doing? Justify the relevance, significance, need, and priority of
conducting the proposed study.
 Specify the intervention regimen(s) and provide justification for the chosen
intervention(s). Describe and justify the route of administration, dosage
regimen, intervention period, frequency and intensity.
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3
AIMS AND OBJECTIVES
The aims should specific, clear, concise, and achievable.
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4
EXPERIMENTAL DESIGN, MATERIALS AND METHODS
Clearly state the type of study design and briefly describe how the proposed design
will answer the research question. Schematic diagrams can be utilized for explaining
unavoidable complexities in the proposed design.
A description of the experimental design should be referenced, where applicable,
and should include:
(i) Already developed and any new methods that will be established or validated.
(ii) Potential difficulties and limitations of the available methods and strategies for
overcoming those methods.
(iii) Methods of identifying the Study population, different groups and arms, the
total sample size, and number of participants in each group/arm (include a table, if
appropriate).
(iv) The methods and procedures of collecting and processing biological samples
(iv) The location of the Study site should be identified. (For example, DIRTP clinics
and laboratories, affiliated institutions, or community),
(v) Other protocol specific details, such as verification and standardization of
laboratory analysis.
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5
STATISTICAL CONSIDERATIONS
5.1 Statistical Methods
Statistical methods vary from one study to another. Include a description of the
APPROPRIATE statistical methods to be employed for the data analysis. State
justifying reasons for choosing such methods. If the analysis will be computer
aided, indicate the name and source of software to be employed.
If the study is hypothesis driven, state the NULL AND ALTERNATE
HYPOTHESES, if applicable.
Provide all information needed to validate SAMPLE SIZE CALCULATION, and also
to judge the feasibility of enrolling and following the necessary numbers of
subjects. Describe sample size calculation with respect to power. Discuss whether
the sample size also provides sufficient power for addressing secondary
objectives or analyses in key subgroup populations.
State expected drop-out, withdrawal, missing data, and approach to minimize
these events.
5.2 Data Collection and Quality Assurance
5.2.1 Data Collection Forms
Describe the methods of collecting information for each participant. Include
a sample of the Data Collection Sheet or Case Report Form (CRF).
5.2.2
Data Management
Briefly describe data management procedures indicating the type of data to
be collected, persons responsible for data collection, and whether necessary
arrangements have been made with the department of Biostatistics and
Epidemiology.
5.2.3
Quality Assurance
Describe mechanism for assuring protocol compliance, documentation, and
record keeping. Indicate if there is a Quality Control Committee, and
necessary training of the study team
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5.3 Interim Analyses and Stopping Rules:
If an interim analysis is planned, describe the rationale, and method for
adjusting calculations. As relevant, provide guidelines for stopping the study
for reasons of early achievement of the objectives, safety, futility, or poor
study performance (For example, slow accrual, high losses-to-follow-up, and
poor quality control etc.).
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6.1
ETHICAL CONSIDERATIONS
Human Subject Involvement
 Indicate whether the study involves Human Subjects. For the purpose of
research, Human subject is defined as an Individual about whom the
investigator obtains information through i) intervention, interaction, or iii)
identifiable private information.
 Characteristics of the study population such as age range, gender, and ethnic
groups, should be provided. The exclusion of certain age, gender, or ethnic
groups, should be justified.
Indicate whether the study involves accrual of special populations (for
example, non-Arabic speakers, children, illiterate individuals, women, and
vulnerable populations). If yes, what extra precautions are taken for the
protection of vulnerable subjects?
6.2
Informed Consent Forms
In this section describe the procedures for obtaining and documenting informed
consent of study participants. Indicate whether an Informed Consent will be
obtained from each participant or the investigators are applying for the Waiver of
Informed Consent.
 Include a copy of the Informed Consent Form (both English and Arabic) or
request for the Waiver of Informed Consent. Request for the waiver should be
properly justified.
 Indicate that for participants with diminished capacity, such as minors and
mentally retarded, who cannot consent for themselves, an authorized
representative will sign the Informed Consent.
 Indicate that the original copy of the consent shall be kept in the investigators’
records, a copy will be given to each participant or legal guardian, and this fact
will be documented in the participant’s record.
 Specify a member of the study team who shall be responsible for implementing
the consenting process and obtaining the Informed Consent of Participants.
6.3
Participants’ Confidentiality
Include statements with regard to maintaining participants’ confidentiality,
procedures for data security, and record retention procedures.
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SAMPLE TEXT:
To maintain confidentiality, all research data, blood and/or tissue specimens,
Consent Forms, Data Collection Forms, reports, video recordings, and other records
that leave the site will be identified only by a Code Number-participant
identification number (Participant ID). All records will be kept in a locked file
cabinet. All computer entry and networking programs will be done using PIDs only.
Participants’ identifiable private information will not be released to a third party
without written permission of the participants. However, the IRB/Ethical Review
Committee and other authorized regulatory bodies may require reviewing the
confidential information.
6.4 Study Discontinuation
Add a statement that the study will be discontinued at any time if the Ethical Review
Committee, the Research Advisory Board, or other authorized government agencies
decide to do so as part of their duties to ensure the protection of research
participants.
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7
PUBLICATION OF RESEARCH FINDINGS
Provide a statement regarding the publication of the study results. How and where
do investigators intend to publish their results?
Sample text:
Investigators will try to prepare manuscript of the publishable data for publication
in high impact scientific journals. Publication of the results of this study will follow
the Manuscript Authorship Guidelines and Policies of the institution. Any
presentation, abstract, or manuscript will be forwarded to the Office of Research
Affairs, prior to submission for publication.
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8
8.1
WORK PLAN (ORGANIZATION AND MANAGEMENT)
THE STUDY TEAM ROSTER
List the exact contribution of and the amount of time expended by each investigator
who plays significant role in the development, design, and execution of the study.
Include contact details of each investigator on the proposal cover sheet.
8.2
TIME FRAME OF EVENTS
The study plan can be divided in several stages (Phases), such as protocol review
and approval, enrollment phase, Intervention Period, Follow up period, Data
Analysis Period, Progress and/or Final Report submission to the ORA, and
Publication of the results. Define timelines for achieving various phases and
milestones of the study.
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9
THE BUDGET
The proposed budget should be itemized and properly estimated. Each item should
be briefly justified. The Budget Form should be adequately completely and attached
as an Appendix.
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10
CONTINGENCY PLANS
In this section, necessary arrangements should be considered for the expected and
unforeseen problems and obstacles. Such eventualities could be the loss of key
personnel, failure to accrue the targeted number of participants, loss to follow up,
unavailability of equipments, supplies, etc.
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REFERENCES
References mentioned in the protocol should be listed in sequential order. Provide
the citations for all publications and presentations referenced in the text of the
protocol. The recommended citation style is given below:
Ray KK, Seshasai SR, Wijesuriya S, Sivakumaran R, Nethercott S, Preiss D, Erqou S,
Sattar N. Effect of intensive control of glucose on cardiovascular outcomes and death
in patients with diabetes mellitus: a meta-analysis of randomised controlled trials.
Lancet. 2009 May 23; 373(9677):1765-72.
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SUPPLEMENTS/APPENDICES
Appendix 1:
Data Collection Form/Questionnaire/Case Report Form (CRF)
Appendix 2:
Informed Consent Form
Appendix 3:
Investigators’ Curriculum Vitae
Appendix 4: Others (Please specify)
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