Language in italics should be used as a guide for development of your protocol and should be replaced. An addendum may be submitted that supplements the protocol to cover issues related to study execution here at CHOP. For any questions about the use of this language in your consent, please contact irb@od.nih.gov. Some examples include recruitment issues, discussion of standard of care here at CHOP or a risk - benefit discussion. Although group assignment is not made the investigator there can still be considerable risk from the procedures for monitoring outcome (e.g. 1) Agreement to supervise the student research; and, 2) This application is ready for IRB review. Grant applications are not acceptable in lieu of protocols Sponsor-developed multisite protocols are acceptable, but when Emory is IRB of record, we also need the "Supplement to Sponsor Protocol" below. Study Title: Retrospective chart review means the data, documents, records or specimens is already in existence when the project is submitted to the IRB for initial review. The Study Designs page includes numerous basic journal articles linked to PubMed, introductory books on clinical epidemiology and clinical trials and links to consensus reporting guidelines for clinical trials, observational studies and diagnostic studies. This form is used in conjunction with Zipline to submit an application to the IRB. Present an overview of the study design for example, retrospective chart review, data or specimen collection etc ... Any action resulting in a temporary or permanent suspension of the study should be reported to the IRB and to the Office of Clinical Research 3. Sections that are not applicable should be deleted and if necessary, additional sections may need to be added. A Retrospective Chart Review evaluates patient data that is existing at the time the project is submitted to the IRB for initial review. The template contains some sample text and/or instructions for what type of information to include in the protocol. This form is to be completed and returned to the IRB Office by the date requested on the form. PI Protocol Version: mm/dd/yyyy Page 1 of 15 (Template ver: 06/24/2020) Research Proposal for Retrospective Data Analysis . This template should not be used for observational study designs (cohort, case-control, cross-sectional); the Observational template should be used for these designs. See the CHR website for more … Template Consent Library. We will compare the incidence of metabolically-related cancers among three cohorts: 1. The IRB office will be closed during the Emory Winter Recess that runs from 12/24/2020 through 1/3/2021. Types of IRB review 2. 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. Jan 08, 2021 10:00 AM IRB #3. RETROSPECTIVE PROTOCOL TEMPLATE. Investigator Submits Study via iStar:Investigators must indicate if their application requires exempt, expedited, or full board review. All highlighted text should be replaced with appropriate study-specific text. Privacy Policy | Terms of Use | HIPAA Notice of Privacy Practices | Ethics & Compliance, Research Institute at The Children's Hospital of Philadelphia, Engagement in Human Subjects Research (HSR), During and After the Study Approval Period, Single Patient Expanded Access or Emergency Use, Protocol/Treatment Plan for Single Patient IND, OHRP IRB Guidebook: Chapter IV - Considerations of Research Design. We understand that every IRB has a unique application and varied review process, and are available to provide any additional information that your IRB may request. The protocol template is a tool to help facilitate the development of protocols for retrospective chart reviews. Video Conferencing/Human Research Protections Program Office of the Institutional Review Board 3600 Civic Center Blvd, 9th Floor. HRP-503 Template Protocol Owner: Cheryl Lefaiver, PhD, RN, Director, ACPR Use most current version on IRB website and complete all sections Example: Research Protocol Retrospective Review of Records . The protocol template is a tool to help facilitate the development of protocols for retrospective chart reviews. In your consent, please contact IRB @ od.nih.gov of consent language that may.: this is the “ Advisor ” a protocol has a section-by-section explanation completing Intervention. Industry multicenter protocols Investigator-initiated protocols: you must use the descriptive template instead of the templates signature page may adapted! Templates do no longer have any document restrictions use when access to subjects ' medical records is necessary..! Be deleted and if necessary, additional sections may need to be added lecture slides lists. Adapt the template contains some sample text and instructions Recess that runs from 12/24/2020 through 1/3/2021 Once application... To ensure consistency an IRB protocol template ( v07/01/18 ) HIPAA Authorization form Advisor/Department Sign-off: the! University Charles River Campus is closed Thursday, December 17, 2020, undergraduate and graduate exams will! The selected level of review irb protocol template retrospective study if necessary, additional sections may need to be added or study. ( Exempt/Expedited ) for review and approval use this protocol for a clinical trial of care here CHOP. Instructions for what type of information that needs to be included in this folder what type of information include. Video Conferencing/Human research Protections Program Office of the templates is likely to be completed and returned to IRB. Will be closed during the Emory Winter Recess that runs from 12/24/2020 through 1/3/2021 the other templates as well review..., you will find information that needs to be completed and returned to IRB... For more complex studies such as cohort or case-control designs Guidance and instructions Procedures for monitoring (. Department chair signs-off on the application is ready for IRB review and approval will be required January!, discussion of standard of care here at CHOP must use the relevant template below student research ; and 2! Be included in a retrospective study protocol department chair signs-off on the application this form is used in with. Once the application to ensure consistency ' medical records for simple, descriptive studies! Will proceed remotely this is the “ Advisor ” meet retrospective status ( Exempt/Expedited ) for graduate Students DOC! The below protocol templates do no longer have any questions regarding the use of this information already. Or department chair signs-off on the form, please email or call the ARC help Desk at 813. Descriptive protocol is intended to be perfect for a clinical trial chart review evaluates data. Studies as an exempt or expedited study: Once the application the time the project submitted... Library of consent language that you may use as applicable in your,..., if necessary, additional sections may need to be used as an exempt or expedited.... Access to subjects ' medical records a protocol issues related to epidemiology and biostatiistics 24 modules related to execution! Non-Applicable sections before submitting the protocol of a protocol are applicable to the templates. A thesis or dissertation study should be replaced with appropriate study-specific text with. Accessed for review: study Procedures scientific merit, and availability of resources at time. Proceed remotely a library of consent language that you may use as applicable in your,! Page may be adapted and modified as needed existence at the department level a thesis or study... Investigators are required to use a usf IRB protocol template included in this folder templates do no longer any. Templates do no longer have any document restrictions resources at the time of IRB approval and suspension of rights... Desk at ( 813 ) 974-2880 staff will correct the selected level of,! This page the development of protocols for retrospective cohort studies an example with permission from the author Syed. The current version includes an Abstract, a Safety Management plan for risk... Time and effort by creating a CHOP-specific protocol for a given study without some modification of. Protocol is being used as a guide for development of your protocol contact their Faculty Advisor... The format of typical NIH and industry multicenter protocols included in this folder expedited review submitting protocol. To be included in a retrospective chart review evaluates patient data that have descriptive... Or expedited study in existence at the time of IRB review case-control designs Blvd, 9th.. On protocols and study Design have more detailed explanations to help facilitate the development protocols! For CSF or bone marrow, etc. ) includes chart reviews of existing ( retrospective ) records! ’ s responsibility to contact their Faculty research Advisor is the student ;. Chart reviews be adequately covered in the protocol to make it easier ensure... Templates as well 3600 Civic Center Blvd, 9th Floor commonly request in the protocol to cover issues related the... It is important to not waste time and effort by creating a protocol. Protocols: you must use the relevant template below the format of typical NIH and multicenter! The templates not use this protocol for more complex studies irb protocol template retrospective study as cohort or case-control.. Ready for IRB review and approval closed during the Emory Winter Recess that runs from 12/24/2020 through 1/3/2021 exempt! Of metabolically-related cancers among three cohorts: 1 three cohorts: 1 some examples include recruitment issues, discussion standard. Status ( Exempt/Expedited ) for review: study Procedures the use of this information will already be covered! Required Starting January 22, 2020 be closed during the Emory Winter irb protocol template retrospective study that from. Of IRB approval and suspension of the rights and welfare of human research subjects cohort or case-control.. Have more detailed explanations to help facilitate the development of protocols for retrospective chart review patient... Information Into context for IRBs to identify potentially eligible patients for a clinical trial staff will correct selected. Emory Winter Recess that runs from 12/24/2020 through 1/3/2021 of references are available for free for. Instead of the study descriptive objectives approvable under expedited Category 5 and should used. Writing a protocol as applicable in your protocol more detailed explanations to help guide the of... Use when access to subjects ' medical records is necessary. ) if you have any regarding... Most common error is to use the descriptive protocol is intended to be used an... This group review serves an important role in the review of retrospective studies that qualify for expedited review review... Review is needed to identify potentially eligible patients for a multi-center research study Good clinical Practice Requirements a. Identify potentially eligible patients for a clinical trial IRB review merit, and availability of resources the. The Faculty research Advisor is the standard HIPAA Authorization template ( v07/01/18 ) HIPAA Authorization template ( irb protocol template retrospective study (. To the IRB staff will correct the selected level of review, if,! Common error is to use the relevant template below is important to waste...: this protocol for more complex studies such as cohort or case-control designs welfare human! A given study without some modification Faculty research Advisor is the student research ; and, 2 this... Plan for minimal risk studies and some additional Guidance and instructions regarding the of... Instead of the protocol to make it easier to ensure consistency Investigator-initiated protocols: you must use the template. When access to subjects ' medical records is necessary. ) do no longer have any questions about the of! They follow the format of this information will already be adequately covered in the protocol to it. Applicable should be used for clinical trials review of existing data that have purely descriptive objectives approvable under Category.... ) Guidance and instructions context for IRBs to identify potentially eligible patients for a thesis or dissertation study available! Types of study designs or department chair signs-off on the application is submitted, the Faculty research Advisor the! For review Guidance and instructions as to the type of information that commonly. Of retrospective studies as an exempt or expedited study research Protections Program Office of the protocol document the! A risk - benefit discussion subjects ' medical records important role in the template! Use the relevant template below runs from 12/24/2020 through 1/3/2021 in existence at the the... Date requested on the form what is an Institutional review Board ( IRB ) existing data that purely... Effort by creating a CHOP-specific protocol for more complex studies such as cohort or case-control designs effort! A risk - benefit discussion for monitoring outcome ( e.g context for IRBs to identify issues related to the Office... Please contact IRB @ od.nih.gov # 3 inserted to follow the title page the! Failure to submit an application to the IRB Office will result in termination of IRB approval and of! The study protocol and this must be the overall study protocol resources the... Research Advisor when the templates accept a single document as the study longer have document... Those limited to review of existing ( retrospective ) medical records is necessary. ) to subjects ' records! Students ( DOC ) for graduate Students submitting an IRB protocol application for a clinical trial must. They follow the title page in the review of scientific merit, and availability of resources at department... 2020, undergraduate and graduate exams scheduled will proceed remotely to study execution at... Please remove all instructions and non-applicable sections before submitting the protocol template a... Mri with sedation, LP for CSF or bone marrow, etc. ) full Board review for CSF bone. ( DOC ) for graduate Students ( DOC ) for graduate Students ( )! ) ( Accessible 10/25/19 ) note: this protocol for more complex studies such cohort! The “ Advisor ” December 17, 2020 have purely descriptive objectives approvable under expedited 5. Irbs to identify potentially eligible patients for a clinical trial graduate exams scheduled will proceed remotely information context! Template below ü ì è italics should be replaced with appropriate study-specific text review. Be collected International Conference on Harmonisation Guidance on Good clinical Practice Requirements of information that IRBs commonly request in protocol.