L Many of these forms are available from institutional websites. ����������������������� hyn j hyn Uh�E� h{S� hAj� hAj� hAj� ' 7 I W ~ � � � � M c ~ � � � � � � � � ~ Protocol title: Protocol number: Study center: Coordinating or Principal Investigator. It is based on a form used by intramural NIH investigators, and was modified as the result of review of many different extramural institutional forms in order to anticipate a variety of research scenarios. � 1. read the Aims & Scopeto gain an overview and assess if your manuscript is suitable for this journal; 2. use the Microsoft Word template or LaTeX template orFree Format Submissionto prepare your manuscript; 3. make sure that issues about publication ethics, research ethics, copyright, authorship, figure formats, data and references formathave been appropriately considered; 4. ensure that all authors have approved the content of the submitted manuscript. STUDY SUMMARY Title A Clinical Investigation Evaluating Efficacy of a Full-Thickness Placental Allograft (Revita) in Lumbar Microdiscectomy Outcomes Methodology Randomized, controlled trial, blind study Study Duration Estimated duration for the main protocol (e.g. It is based on a form used by intramural NIH investigators, and was modified as the result of review of many different extramural institutional forms in order to anticipate a variety of research scenarios. Reviews of methodological issues need to contain at least one outcome of direct patient or clinical relevance in order to be included in PROSPERO. Study Protocols 2 of 10 CVB Reviewers’ Manual The considerations for a particular protocol are highly dependent upon the type of study being performed. Animal Monitoring sheet template (DOCX, 13.79 KB) example one The following guide is designed to offer practical tips for investigators when preparing an application. Fox Foundation for Parkinson‟s Research 90 Broad Street, 10th Floor New York, NY 10004 How did we determine an UPT is needed? We anticipate changes to this document as institutional comments are received and as animal research and the policies that govern it evolve. : CTJ301UC201 Solution for Injection Clinical Trial Protocol Leading Biopharm Limited CONFIDENTIAL CLINICAL TRIAL PROTO. } The Local Protocol Addendum should be uploaded along with the main protocol document in eIRB+ and modified as necessary throughout the duration of the study to … The following is a list of general considerations, not all of which apply to every study. The template guidance is only intended to help you draft the document and should not be retained in the final version. GUIDELINES FOR DESIGNING A CLINICAL STUDY PROTOCOL (based on International Conference on Harmonization, GCP Guidelines for Clinical Trial Protocol development) To draft a sound scientific design of a clinical research study, the medical writer at the TGH, Office of Clinical Research recommends that the following information should be included in a research protocol. � � � � � � � � � � � � � � � � � � � � � � � � � � � The first type of trials are Phase 2 and 3 clinical trial protocols that require a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) application. Most institutions have instituted an animal care and use protocol form that investigators are required to complete and submit to the IACUC. Guide to completing the CDU AEC Project and Permit application (PDF, 855.7 KB) A protocol format for the preparation, registration and publication of systematic reviews of animal intervention studies; 7; Guidelines for assessment of bone microstructure in rodents using micro-computed tomography; 8; A systematic review of systematic reviews and meta-analyses of animal experiments with guidelines for reporting; 9 Please. animal and clinical study protocol template. � National Institutes of Health (NIH), OLAW: Animal Study Proposal Institutions may download the form and modify it to suit their own institutional program and needs. To the greatest extent possible, pre-emptive euthanasia should be advocated for any study in which an animal is likely to progress to a moribund state (impending death). In the training session, each participant will be designated to one of four experimental conditions based on his or her gender, demographics and sensation seeking score (Zuckerman M, 1994). Sarepta Therapeutics, Inc. Study 4045-301, Version 6 Page 1 03 April 2017 Confidential . Inclusion criteria (human clinical trial only): Exclusion criteria (human clinical trial only): % & � � � � � � � &. As able, ensure the area is well ventilated. If a study is USDA Classification E, describe any non-pharmaceutical methods that will be used to minimize pain and distress. � Research protocol The present study evaluates hazard perception training programs for young-inexperienced drivers. Systematic review protocols registered on PROSPERO can include studies of any design. Have all material safety data sheets or product safety data sheets for cleaning and disinfection materials available. This second example is for an observational protocol. Registering to eProtocol – In order for any individual to be listed on an Animal Use Protocol they must be provisioned an account in e-Protocol by completing the e-Protocol registration. Drexel University. The new system will allow faculty, researchers and staff to submit new animal protocols, and to modify these new protocols. Session Discussion Points 1. Number of study centers (if more than one): Phase of study: Objectives: Next Steps 6. Registration can be completed at: Document Description; IACUC Protocol Instructions and Checklist (DOC) Instructions and checklist for submitting an IACUC Protocol Application: Observation Only Study Checklist (DOC) If your study only involves observational procedures, use this checklist to see if your study requires IACUC review. Checklist. The template is based on Art 38 of Implementing Regulation No 520/2012 with the additional instructions of Module VIII of the Good pharmacovigilance practices. The research protocol should provide the information needed for reviewers to determine that the regulatory and Human Research Protection Program (HRPP) policy requirements have been met. MJFF-001 Clinical Study Protocol CONFIDENTIAL Final Page 1 of 58 02 December 2009 Clinical Study Protocol Variability of Parkinson’s Disease Biomarker Analytes Sponsor: Michael J. COL. A Phase II, Randomized, Double -blind, Placebo -controlled Study to Evaluate the Safety and Efficacy of TJ301 (FE 999301) Administered Intravenously in Patients with Active Ulcerative Colitis • Animal care • Study endpoint • Animal welfare • Biohazard/safety • Surgery • Qualification of personnel • Blood or body fluid withdrawal/tissue collection/injections, tail clip, gavaging Protocol Writing Protocol Title This is an animal protocol, therefore it must have animal listed in the title *** Effect of Antigen A on Vaccine Efficacy. Comments should be sent to: olawdpe@mail.nih.gov. Local Protocol Addendum Template (HRP-508) This document contains local information not represented in the main protocol document received from a study sponsor or non-Northwestern University research collaborator. The sample animal study proposal is provided in response to requests from many institutions that wish to develop or revise an animal care and use protocol form intended for internal institutional use. Institutional Animal Care and Use Committee Protocol Form Instructions T h efor mi s dula n c t .AC ( ) b p y Attachments may need to be completed depending on your responses to the checklist in Section V of the Core. 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 protocol template aims to facilitate the development of two types of clinical trials involving human participants. Contact the Division of Policy and Education by phone at 301-496-7163 or e-mail to olawdpe@mail.nih.gov. Animal Study Proposal v12/8/2015 3 • Other potential stressors [e.g., noxious stimuli, environmental stress] and procedures to monitor and minimize distress. M � Community Input and FDP Involvement 4. Submit, for each animal toxicology study that is intended to support the safety of the proposed clinical (i.e., human) research study, a full tabulation of the respective data suitable for detailed review. Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 statement; 8; Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide; 9; Guidance for reporting intervention development studies in health research (GUIDED): an evidence-based consensus study; 10 All young-inexperienced drivers will undergo a training session. Sections may be added, deleted, or modified to meet the needs of individual programs. Georgetown University. Note that the procedures in Section 4 are simply bullet points and these match the Table of Procedures. bjbjqPqP . When submitting comment… Estimated Timeline 7. � The sample animal study proposal is provided in response to requests from many institutions that wish to develop or revise an animal care and use protocol form intended for internal institutional use. This template should not be used for observational study designs (cohort, case-control, cross-sectional); the Observational template should be used for these designs. 1. TJ301 Protocol No. However, in general, many IACUCs have found that use of a protocol form helps research investigators to delineate the information that the IACUC requires in order to review a proposal, and also helps the IACUC to achieve greater consistency in its review. There is great variation in the length, format, content, and use of these forms, and a form that serves one institution well may not necessarily prove successful at another institution. This is an animal protocol, therefore it must have animal listed in the title ... • Characteristics of the species make it uniquely suited for the study Protocol Writing 7.2.1 Animal model and Species justification Justification of the selected species (con’t) • Describe the characteristic of the animal that make appropriate for the study. We are interested in your comments on the content of this sample animal study proposal and in your suggestions for additions, deletions, or revisions. What made us think an UPT would be useful? DRUG: SRP-4045 Injection and SRP-4053 Injection � Study Plan/Protocol Review Process •Standard study plan/protocol templates - reviewed by IACUC committee for all standard study types - templates reflect the regulatory requirements for basic parameters -additional parameters required must be reviewed and approved prior to ordering the animals/prior to animal arrival Individuals who have not registered will not have access to e-Protocol and will not be available for selection as study team members in the system. If you wish to use the sample animal study proposal as a template, click one of the formats below to download. Work is underway to facilitate the inclusion of reviews of pre-clinical studies. ��ࡱ� > �� + - ���� * �������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� q` �� � Other online submissions for electronic protocols … Status Update 5. Laboratory Use. Submit electronic comments to www.regulations.gov. Action is taken as per the study protocol and includes euthanizing the animal, stopping a painful procedure, or alleviating the pain or distress with other appropriate measures. The details of each of the study procedures are in Section 5, where a short paragraph describes each procedure. Individuals not familiar with the PHS Policy are encouraged to visit the PHS Policy Tutorial. N The animal activity proposal should describe how experimental and medical records will be maintained to show that the protocol has been carried out as approved. The general goals behind developing a UPT 3. 1. Remove all template guidance before you attach the file to the submission. | Animal Utilization Proposal Form Protocol # AUP-2020-05-13318-----Protocol Title: Sample Form_2020 Approval Period: Draft Important Note: This Print View may not reflect all comments and contingencies for approval. There is no required format or template; different sections and formatting may be used, provided the necessary information is included. R j � ' 0 W x � � x Use the template to build your initial protocol document. ***** This document is intended to be an aid in the preparation of an U.S. Air Force DOD – sponsored animal use proposal. Investigators should design this record-keeping para-digm before starting the study, so that they are ready for post-approval IACUC monitoring visits and USDA regulatory visits. For interventional PASS, instructions provided in Volume 10 of the Rules Governing Medicinal products in the European Union should be followed. Sample environmental cleaning and disinfection protocol . � Objective . � The following template provides essential topics of interest that the IRB looks for during review. Protocol No. Institutions may download the form … The use of this sample animal study proposal is not required and is provided for the convenience of Institutional Animal Care and Use Committees (IACUC) at Assured institutions. Carleton University, Ottawa, Ontario: Lab Animal Use Protocol, Wildlife Protocol, and Pedagogical Merit Review forms. Q/A. � ~ animal and/or clinical study Protocol. IACUC Forms and Templates. Follow instructions for proper mixing, disposal, and PPE (e.g., gloves, eye protection). CLINICAL STUDY PROTOCOL . You may submit written comments and suggestions at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. National Institutes of Health (NIH), 9000 Rockville Pike, Bethesda, Maryland 20892, U.S. Department of Health & Human Services, PHS Policy on Humane Care and Use of Laboratory Animals, Guide for the Care and Use of Laboratory Animals (PDF), AVMA Guidelines for the Euthanasia of Animals (external PDF), Semiannual Program Review and Facility Inspection Checklist, Semiannual Report to the Institutional Official, Sample Documents for Implementation of the PHS Policy on Humane Care and Use of Laboratory Animals, Download the sample animal study proposal, Description of Experimental Design and Animal Procedures, Pain or Distress Classification and Consideration of Alternatives, Anesthesia, Analgesia, Tranquilization, Other Agents, Methods of Euthanasia or Disposition of Animals at End of Study, Biological Material/Animal Products for Use in Animals, Exemptions from Environmental Enrichment for Nonhuman Primates or Exercise for Dogs, Special Concerns or Requirements of the Study, Appendix 1 - USDA Classifications and Examples, Attachment 1 - Explanation for USDA Classification E, U.S. Department of Health and Human Services, PHS Policy on Humane Care and Use of Laboratory Animals, 2015. The study design is cross-sectional, meaning that there is just one study visit. 2. The protocol should clearly state the nature and purpose of the study. Modifications can be made by submitting protocol change requests, and study team updates. Animal Subjects Subcommittee–January 12, 2021 Universal Protocol Template (UPT) Update. � � � L � � � � � � � � � � � N R � � � W � � � � ` ` ` d ` ` ` d ` ` ` L L L L L L ���� animal and/or clinical study Protocol Protocol title: Protocol number: Study center: Coordinating or Principal Investigator Number of study centers (if more than one): Phase of study: Objectives: Methodology: Number of human subjects or animals for this study: Diagnosis and Main Criteria for Inclusion (for human clinical phase): Number of treatments: Dosing for each treatment: Duration of each treatment: Criteria for Evaluation: Statistical Methods: Measures: Safety: Efficacy: Pharmaco-kinetics: Others: List all other measures here. : : ~ �� �� �� � L L L L L L L ` d d d 8 � � ` W 2 � � � � � � � � � � � � � � � $ � h � � � L � � � � � � L L � � � � � � ^ L � L � � � � � � � r T L L � � Ph�Gi�� d & TITLE PAGE . 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