animal study protocol template

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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. DRUG: SRP-4045 Injection and SRP-4053 Injection bjbjqPqP . Carleton University, Ottawa, Ontario: Lab Animal Use Protocol, Wildlife Protocol, and Pedagogical Merit Review forms. 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. Systematic review protocols registered on PROSPERO can include studies of any design. Study Protocols 2 of 10 CVB Reviewers’ Manual The considerations for a particular protocol are highly dependent upon the type of study being performed. We anticipate changes to this document as institutional comments are received and as animal research and the policies that govern it evolve. 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 Sarepta Therapeutics, Inc. Study 4045-301, Version 6 Page 1 03 April 2017 Confidential . 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. 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. Laboratory Use. Institutions may download the form and modify it to suit their own institutional program and needs. Most institutions have instituted an animal care and use protocol form that investigators are required to complete and submit to the IACUC. We are interested in your comments on the content of this sample animal study proposal and in your suggestions for additions, deletions, or revisions. 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 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. 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. Animal Subjects Subcommittee–January 12, 2021 Universal Protocol Template (UPT) Update. Comments should be sent to: olawdpe@mail.nih.gov. 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 2. Note that the procedures in Section 4 are simply bullet points and these match the Table of Procedures. | 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. � � � 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. N &. 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. Next Steps 6. ***** This document is intended to be an aid in the preparation of an U.S. Air Force DOD – sponsored animal use proposal. 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. � Use the template to build your initial protocol document. Follow instructions for proper mixing, disposal, and PPE (e.g., gloves, eye protection). Other online submissions for electronic protocols … � 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). : : ~ �� 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 & Remove all template guidance before you attach the file to the submission. Guide to completing the CDU AEC Project and Permit application (PDF, 855.7 KB) � : CTJ301UC201 Solution for Injection Clinical Trial Protocol Leading Biopharm Limited CONFIDENTIAL CLINICAL TRIAL PROTO. ��ࡱ� > �� + - �� * �� q` �� 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. Individuals not familiar with the PHS Policy are encouraged to visit the PHS Policy Tutorial. The following is a list of general considerations, not all of which apply to every study. 1. Research protocol The present study evaluates hazard perception training programs for young-inexperienced drivers. 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. Community Input and FDP Involvement 4. 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. Reviews of methodological issues need to contain at least one outcome of direct patient or clinical relevance in order to be included in PROSPERO. 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. Submit electronic comments to www.regulations.gov. R j � ' 0 W x � � x �� hyn j hyn Uh�E� h{S� hAj� hAj� hAj� ' 7 I W ~ � � � � M c ~ � � � � � � � � The protocol should clearly state the nature and purpose of the study. The study design is cross-sectional, meaning that there is just one study visit. 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). The details of each of the study procedures are in Section 5, where a short paragraph describes each procedure. Georgetown University. How did we determine an UPT is needed? 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