It is expected that the investigator will adapt the template to suit their needs. Sections that are not applicable should be deleted and if necessary, additional sections may need to be added. The most common error is to use the Descriptive template instead of the Observational template for retrospective cohort studies. The descriptive protocol is intended for simple, descriptive research studies, particularly those limited to review of existing retrospective medical records. Do not use this protocol for more complex studies such as cohort or case-control designs.
Try to limit the amount of repetition across the various sections of the protocol to make it easier to ensure consistency. This template should only be used for for studies limited to 1 the use of existing data or specimens, 2 where the only study procedure is a retrospective chart review or use of existing biological samples and 3 where the analysis plan is limited to purely descriptive summary statistics. This template should not be used for observational study designs cohort, case-control, cross-sectional ; the Observational template should be used for these designs.
This template is intended for observational studies - those without an active study intervention - including cohort, case-control, cross-sectional and prospective descriptive study designs. Observational studies are those where the assignment of subjects to groups is determined by nature, serendipity, the subject, or the subjects' clinicians rather than by the investigator. Although group assignment is not made the investigator there can still be considerable risk from the procedures for monitoring outcome e.
This template is intended to be used for clinical trials. Clinical trials are intended in their broadest sense and means any study design that involves an intervention regardless of the nature of that intervention drug, biologic, device or other treatment strategy or method of treatment assignment non-random process or randomization.
The current version includes an Abstract, a Safety Management plan for minimal risk studies and some additional guidance and instructions. When the overall PI for a multi-center study is from CHOP, the protocol should have a signature page to document that the other site investigators agree to conduct the research in accordance with the federal regulations.
Try using a different browser such as Chrome, Edge, Firefox, or Safari. Pre-Award and Post-Award Processes. Protocol Templates for Clinical Trials NIH applicants can use a template with instructional and sample text to help write clinical protocols for the following types of research: Phase 2 or 3 clinical trials that require Investigational New Drug applications IND or Investigational Device Exemption IDE applications Behavioral and social sciences research involving humans These clinical protocol templates can be accessed via the secure web-based e-Protocol Writing Tool and as Word templates Clinical E-Protocol Writing Tool.
Benefits of the e-Protocol Writing Tool include: enables participation for multiple writers and reviewers allows assignments for writers and collaborators tracks progress and ensure document version control The use of these templates is recommended, but not required. Student Corner. Log In. Log in via Email. Forgot your password? Create Your Account. We will not share your email with anyone.
Password must be at least 8 characters. Show or Hide the password you are typing. Create your account Back. Request to Join has invited you to join this group. Accept Request Ignore. Period of enrollment or chart review covers? Informed consent? Study Population Who? Age, Sex, Race, Diagnoses if appropriate.
Control group C. Assessment of Resources Indicate how investigator will ensure that the study: 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.
Study Procedures Include a description of the study procedures as they relate to the subject. Explain what information will be used to identify potential human subjects for inclusion in research. Sample Size Considerations Power analysis based on previous studies or exploratory study? Justifying the sampling procedure B.
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