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Template of Research Protocol for Interventional Studies

Protocol Template, Version # ….., Date: DD/MM/YY Page i

PREFACE

This Protocol Template is a suggested format for INTERVENTIONAL STUDIES to be undertaken by the investigators of “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 sub-headings 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.

Protocol Template, Version # ….., Date: DD/MM/YY Page ii

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)

Protocol Template, Version # ….., Date: DD/MM/YY Page iii

Contents

1 ABSTRACT OR PRÉCIS.............................................................................................................................

2 INTRODUCTION (Rationale and Background Information).......................................................

2.1 Background Information..........................................................................................................................

2.2 Study Rationale............................................................................................................................................

3 AIMS AND OBJECTIVES............................................................................................................................

4 STUDY DESIGN, MATERIAL AND METHODS.....................................................................................

4.1 Experimental Design..............................................................................................................................

4.2 Material and Methods............................................................................................................................

5 SELECTION AND ENROLLMENT OF STUDY PARTICIPANTS........................................................

5.1 Eligibility Criteria........................................................................................................................................5.1.1 Inclusion Criteria........................................................................................................ 65.1.2 Exclusion Criteria......................................................................................................................7

5.2 Enrollment Procedures.........................................................................................................................

6 STUDY INTERVENTIONS.........................................................................................................................

6.1 Management of Study Interventions.............................................................................................

6.2 Concomitant Interventions.................................................................................................................6.2.1 Required Interventions............................................................................................................. 96.2.2 Prohibited Interventions.......................................................................................................... 96.2.3 Precautionary Interventions................................................................................................10

6.3 Adherence Assessment/Evaluation............................................................................................10

7 CLINICAL AND LABORATORY EVALUATIONS................................................................................ 11

8 STATISTICAL CONSIDERATIONS....................................................................................................... 12

8.1 Statistical Methods................................................................................................................................12

8.2 Data Collection and Quality Assurance.....................................................................................128.2.1 Data Collection Forms.............................................................................................................128.2.2 Data Management......................................................................................................................128.2.3 Quality Assurance......................................................................................................................12

8.3 Interim Analyses and Stopping Rules........................................................................................13

9 ETHICAL CONSIDERATIONS................................................................................................................ 14

9.1 Human Subject Involvement...........................................................................................................14

9.2 Informed Consent Forms...................................................................................................................14

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9.3 Participants’ Confidentiality...........................................................................................................14

9.4 Study Discontinuation.........................................................................................................................15

10 PUBLICATION OF RESEARCH FINDINGS....................................................................................... 16

11 WORK PLAN (Organization and Management)..........................................................................17

11.1 The Study Team Roster......................................................................................................................17

11.2 Time Frame of Events..........................................................................................................................17

12 THE BUDGET......................................................................................................................................... 18

13 CONTINGENCY PLANS......................................................................................................................... 19

14 REFERENCES.......................................................................................................................................... 20

15 SUPPLEMENTS/APPENDICES........................................................................................................... 21

Protocol Template, Version # ….., Date: DD/MM/YY Page v

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.

Protocol Template, Version # ….., Date: DD/MM/YY (RA FORM 001)

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 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.

2.2 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.


3 AIMS AND OBJECTIVES

The aims should specific, clear, concise, and achievable.

State primary objectives and secondary objects, if applicable, under separate sub-headings.


4 STUDY DESIGN, MATERIAL AND METHODS

4.1 Experimental Design

Description of the experimental design should be referenced, where applicable.

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.

4.2 MATERIAL AND METHODS

NOTE: This section mainly applies for Basic Research studies.

Material and Methods 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) The methods and procedures of collecting and processing biological samples

(iv) The location of the Study site should be identified. (For example, DDI clinics and laboratories, affiliated institutions, or community),

(v) Other protocol specific details, such as verification and standardization of laboratory analysis.


5 SELECTION AND ENROLLMENT OF STUDY PARTICIPANTS

5.1 Eligibility Criteria

This section should define and describe the study population.

Eligibility criteria, often referred to as “Inclusion and Exclusion criteria” are medical and/or social standards determining whether a person may or may not be allowed to enter a clinical study. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not meant for rejecting people personally, but rather to identify appropriate participants for the study and to maintain their safety.

The selection and enrollment of participants (who are reasonably representative of the populations or characteristics under investigation) is the key component of a successful clinical study.

Include 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).

The location of the Study site should be identified. (For example, DDI clinics and laboratories, affiliated institutions)

5.1.1 Inclusion Criteria

Provide a statement that participants must meet all of the inclusion criteria to participate in this study; list the criteria; briefly justify each criterion in the list. To clearly define the study population, list as many criteria as necessary. The following parameters can be used for setting the inclusion criteria:

Demographic characteristics such as age, gender, current state of health, past medical history, the presence or absence of another medical condition etc.

Baseline physical examination, laboratory results, diagnostic methods, criteria for classification of current health status. List specific tests, procedures, and documentation methods.

Stage of the disease and prior therapy, if any. Consider listing specific prior treatments. Consider listing the allowable duration of prior therapy for the


specific population to be studied (e.g., treatment-naïve, treatment-experienced or prior-treatment-failed “salvage” participants).

Ability to understand study procedures and to comply with them for the entire length of the study.

If men and women of reproductive capability will be enrolled, indicate whether contraception is necessary and required. If yes, include details of allowable contraception methods.

5.1.2 Exclusion Criteria

To clearly delineate the study population, list as many exclusion criteria as necessary. Then list the criteria and briefly justify each criterion in the list. The following parameters can be used for setting the exclusion criteria:

Specify health status or any clinical conditions (e.g., Age limit, life expectancy, co-existing disease or condition, or other characteristics that precludes appropriate diagnosis, treatment or follow-up in the trial.

Clinical/laboratory indicators of current status, obtained within XX days prior to randomization. List the specific tests to be performed and the narrowest acceptable range of laboratory values for exclusion, consistent with disease and/or safety. Include as many as necessary.

Specify any exclusion related to pregnancy, lactation, or plans to become pregnant. Specify methods for assessing current status and willingness to use contraception, if applicable. Include as many as necessary.

Use of [excluded drugs, behavioral interventions, devices, etc.] within XX days prior to study entry. Treatment with another investigational drug or intervention (with time frame).

For drug studies: allergy/sensitivity to study drugs or their ingredients.

Cancer and/or other chronic debilitating disease

Current drug or alcohol use or dependence that, in the opinion of the investigators, would interfere with adherence to study requirements.

Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

5.2 Enrollment Procedures

Describe the method for identifying and recruiting candidates for the trial.


Describe baseline assessment and eligibility of participants.

Describe procedures for the documentation of reasons for ineligibility and for non-participation of eligible candidates (e.g. Screening Log).

Describe consent procedures, including any special requirements (e.g., consent for individuals who are unable to consent for themselves),

For randomized studies, describe the randomization procedure(s) for assigning participants to different arms of the study.


6 STUDY INTERVENTIONS

NOTE: This section mainly applies for Interventional clinical studies. The entire section can be deleted if the study does not involve an intervention.

If applicable, provide the details of each study intervention in terms of the type of intervention, its administration, and duration.

For Example: If the intervention is an Investigational Drug, provide the route of administration, formulation, dosage, frequency of administration etc. If it is a new procedure, describe the nature, site, extent, and performance of the procedure.

6.1 Management of Study Interventions

State the potential side effects of intervention(s). Include guidelines for appropriate supportive care, medications, or treatments of the side effects.

If applicable, state blinding (masking) procedures the study interventions.

Include instructions for maintaining intervention accountability records.

Ideally, investigators need to develop Standard Operating Procedures (SOPs) or the Manual of Operations for the study, which provide detailed instructions for maintaining study records. If such a document is prepared, it can be referenced instead of providing details.

6.2 Concomitant Interventions

Concomitant Interventions might be required as an essential component of the study design or as a consequence of the study outcomes i.e., occurrence of certain side effects, complications, adverse events etc.

If necessary, concomitant interventions such as Required Interventions, Prohibited Interventions, and Precautionary Interventions should be stated.

6.2.1 Required Interventions

Include mandatory modifications to the study interventions, if applicable.

6.2.2 Prohibited Interventions

Include medications, treatments, and the use of certain devices if they are prohibited while the subject remains on the study.


6.2.3 Precautionary Interventions

Precautionary Interventions are meant to enhance the safety profile of study interventions. If applicable, include precautionary measures to avoid anticipated side effects, adverse events, poor outcomes, etc.

6.3 Adherence Assessment/Evaluation

Specify how the subjects’ compliance with the protocol specific interventions and procedures will be assessed.

Include the exact mechanism and tools of assessment such as assessment questionnaires, study diaries, pill counts, electronic monitoring devices, telephone calls, etc.


7 CLINICAL AND LABORATORY EVALUATIONS

Ideally, a tabulated Schedule of Evaluations, which indicates all study specific evaluations, should be included.

Include a table (Schedule of Evaluation) that reflects protocol specific procedures. Check cells with ‘X’ to indicate that a particular evaluation is supposed to be performed at a particular study visit.


8 STATISTICAL CONSIDERATIONS

8.1 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.

8.2 Data Collection and Quality Assurance

8.2.1 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).

8.2.2 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.

8.2.3 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


8.3 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.).


9 ETHICAL CONSIDERATIONS

9.1 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?

9.2 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.

9.3 Participants’ Confidentiality

Include statements with regard to maintaining participants’ confidentiality, procedures for data security, and record retention procedures.


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.

9.4 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.


10 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.


11 WORK PLAN (ORGANIZATION AND MANAGEMENT)

11.1 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.

11.2 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, and Publication of the results. Define timelines for achieving various phases and milestones of the study.


12 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.


13 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.


14 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.


15 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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