Provide a description of the Informed Consent Process, including: Explain what information will be used to identify potential human subjects for inclusion in research. Duration of the Project The protocol should specify the time that each phase of the project is likely to take, along with a detailed month by month timeline for each activity to be undertaken.
If experimental, it may be described as a controlled or a non controlled study. For the same reason, each new intervention also requires a separate informed consent form. Assessment of Resources Indicate how investigator will ensure that the study: Informed Consent Forms The approved version of the protocol must have copies of informed consent forms ICFboth in English and the local language in which they are going to be administered.
Alternative treatment or procedures c Unforeseen risks a Provisions for medical and professional intervention b Reporting adverse events a Where and from whom medical thereapy may be obtained b Who will pay for writing research protocols template therapy c Whom to contact in case of injury C.
The magnitude, frequency, affected geographical areas, ethnic and gender considerations, etc of the problem should be followed by a brief description of the most relevant studies published on the subject.
Costs to Subject Applies to studies using human subjects 1. When determining compensation, keep in mind what is reasonable based writing research protocols template the time and effort required of the subject.
Outline the sharing of data with others outside of the institution, and include provisions for maintaining writing research protocols template. Data Management and Statistical Analysis The protocol should provide information on how the data will be managed, including data handling and coding for computer analysis, monitoring and verification.
Quality Assurance The protocol should describe the quality control and quality assurance system for the conduct of the study, including GCP, follow up by clinical monitors, DSMB, data management etc.
Has sufficient access to the study population Has sufficient time to conduct and complete the study Has adequate qualified staff members to conduct the study Facility is adequate to conduct the study Staff has been adequately trained on the protocol and their specific research related duties D.
For example, a study may be described as being a basic science research, epidemiologic or social science research, it may also be described as observational or interventional; if observational, it may be either descriptive or analytic, if analytic it could either be cross-sectional or longitudinal etc.
It should also describe how the investigator s plan to obtain informed consent from the research participants the informed consent process. This may include a follow u, especially for adverse events, even after data collection for the research study is completed.
For projects involving qualitative approaches, specify in sufficient detail how the data will be analysed. It should also offer possible solutions to deal with these difficulties. Study Design The scientific integrity of the study and the credibility of the study data depend substantially on the study design and methodology.
This should not be limited to providing information on how or from whom the ethics approval will be taken, but this section should document the issues that are likely to raise ethical concerns. Interventions could also be in the realm of social sciences for example providing training or information to groups of individuals.
This can include procedures for recording and reporting adverse events and their follow-up, for example. Explain the benefit to general science or others if applicable.
Recommended format for a Research Protocol Part 1 Project summary Like the abstract of a research paper, the project summary, should be no more than words and at the most a page long font size 12, single spacing. Instruments, rating scales, consent forms, etc.
Study Procedures Include a description of the study procedures as they relate to the subject. Follow-Up The research protocol must give a clear indication of what follow up will be provided to the research participants and for how long.
Clearly describe the financial costs that the subject may incur if there are none, state as much. Additionally, describe how the results of the data will be used i. Plan for Record Retention and Disposal 4. Provisions for vulnerable subjects Applies to studies using human subjects Indicate whether there will be vulnerable subjects in the study Describe additional protections provided to these subjects to protect their rights and welfare G.
The link below provides more information on how to describe a research study Click here Methodology The methodology section is the most important part of the protocol.
If multiple sites are engaged in a specified protocol, methodology should be standardized and clearly defined. After statement of the primary objective, secondary objectives may be mentioned.
In the case of a randomized controlled trial additional information on the process of randomization and blinding, description of stopping rules for individuals, for part of the study or entire study, the procedures and conditions for breaking the codes etc.A Introduction.
Study Abstract. 3. A2. Primary Hypothesis. 3. A3. Purpose of the Study Protocol. 3. B Background. 3. B1. Prior Literature and Studies. 3. B2. The NIH provides many resources for protocol development to assist investigators in writing and developing clinical research protocols that are in compliance with regulatory/GCP requirements.
Some NIH institutes have a mandatory requirement for using their protocol template. For more information on protocol resources at UCSF and for a video with information about protocol. INSTRUCTIONS for use of this protocol template. Once you feel you have completed all elements of the protocol (or local protocol addendum) that applies to your study, delete all instruction text and text throughout the template that does not apply.
Sample Research Protocol Subject: sample research protocol Author: vhaporwhites. The first step in writing a protocol is to decide on the appropriate study design to address the research question.
Clinical research is either experimental or observational. The general advice is applicable to the other protocol templates.
Guidelines for Writing Protocols. A generic safety plan for greater then minimal risk research is. Research Protocol - Example 1 Research Protocol - Example 2 1.
Research Design The goal of this research is to gain some insight into the role of rationality in decision or by asking players to first write down how they would respond if they were the other player.
As another example, the participant might hear. This template is intended for protocols that don't involve research per se other than to collect data or biospecimens for research in the future.
When the information collected is limited to data, this is considered a Registry and collections of biospecimens with or without accompanying data are considered a Repository.Download