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Clinical Trials Protocol Template

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Clinical Trials Protocol Template PREFACE Remove this Preface before finalizing and distributing the clinical trial protocol. This Clinical Trial Protocol Template is a suggested format for Phase 2 or 3 clinical trials supported by the National Institutes of Health (NIH) that are being conducted under a Food and Drug Administration (FDA) Investigational New Drug Application (IND) or Investigational Device Exemption (IDE). Investigators for such trials are strongly encouraged to use this template when developing protocols for NIH supported clinical trial(s). However, others may also find this template beneficial for other clinical trials not named here. This template is provided to aid the investigator in writing a comprehensive clinical trial protocol that meets the standard outlined in the International Conference on Harmonisation (ICH) Guidance for Industry, E6 Good Clinical Practice: Consolidated Guidance (ICH-E6). In order to facilitate review by NIH and FDA, investigators should retain the sections in the order provided. How To Use This Template Throughout this template, the user will find three different types of text: instruction, explanatory and example. Instruction and explanatory text are indicated by italics and should either be replaced in your protocol with appropriate, trial specific text or deleted. Footnotes to instructional text should also be deleted. Example text is included to further aid in protocol writing and should either be modified to suit the drug or device, design and conduct of the planned clinical trial or deleted. Example text is indicated in [regular font]. Within example text, a need for insertion of specific information is notated by <angle brackets>. If this document is used to develop your clinical trial protocol, as noted above, instruction and explanatory text must be deleted and example text must be removed or revised to suit your study. Alternatively, an accompanying blank protocol template shell is provided and may be used. The blank protocol template shell does not contain instruction, explanatory and example text. It only includes the headers below which the writer can add protocol text for the specific study. The headers include styles to generate a table of contents. Version control is important to track protocol development, revisions and amendments, and to ensure that the correct version of a protocol is used by all staff conducting the study. With each revision, update the version number and date located on the bottom of each page. When making changes to an approved and “final” protocol, it is recommended to maintain a summary of the changes. References Relevant references that may be useful when drafting a clinical trial protocol include: nd Citing Medicine, 2 edition: The NLM Style Guide for Authors, Editors, and Publishers CMS: Clinical Laboratory Improvement Amendments CONSORT statement FDA: Compliance Actions and Activities FDA: Federal Food, Drug, and Cosmetic Act (FD&C Act) a FDA: Food and Drug Administration Amendments Act (FDAAA) of 2007 FDA Guidance for Industry, Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring FDA Guidance for Clinical Investigators, Sponsors, and IRBs, Adverse Event Reporting to IRBs – Improving Human Subject Protection FDA: Regulations Relating to Good Clinical Practice and Clinical Trials HHS: The HIPAA Privacy Rule ICH Guidance for Industry, E6 Good Clinical Practice: Consolidated Guidance ICH Guidance for Industry, M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals ICH Guideline for Industry, E3 Structure and Content of Clinical Reports ICH Guidance for Industry, E9 Statistical Principles for Clinical Trials ICMJE: Recommendations ISO Clinical Investigation of Medical Devices for Human Subjects -- Good Clinical Practice (ISO 14155:2011) NIH Guide Notice: Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome- Wide Association Studies (GWAS) NIH Guide Notice: Required Education in the Protection of Human Research Participants NIH: Award Management NIH: Certificates of Confidentiality (CoC) Kiosk NIH: Detailed Application Instructions for Certificate of Confidentiality: Extramural Research Projects NIH: Financial Conflict of Interest NIH: NIH Grants Policy Statement, Section 8.2 Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Research Resources NIH: Inclusion Of Women And Minorities As Participants In Research Involving Human Subjects- Policy Implementation Page NIH: NIH Public Access Policy Details OHRP: Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events OHRP: Human Subject Regulations Decision Charts OHRP: Informed Consent Checklist OHRP: IRBs and Assurances OHRP: Policy & Guidance Index OHRP: Vulnerable Populations OHRP: Tips on Informed Consent 21 CFR Part 11: Electronic Records, Electronic Signatures 21 CFR Part 50: Protection of Human Subjects 21 CFR Part 56: Investigational Review Boards 21 CFR Part 312: Investigational New Drug Application 21 CFR Part 812: Investigational Device Exemptions 45 CFR Part 46; Protection of Human Subjects Research b <Title> The title should be easy to remember, recognizable by administrative support staff, and sufficiently different from other protocol titles to avoid confusion. Brevity with specificity is the goal. Protocol Identifying Number: < Number> Principal Investigator: < Principal investigator> IND/IDE Sponsor: <Sponsor name, if applicable> Do not include IND/IDE number Sponsor means an individual or pharmaceutical or medical device company, governmental agency, academic institution, private organization, or other organization who takes responsibility for and initiates a clinical investigation. Funded by: < NIH Institute & Center (IC)> Draft or Version Number: v.<x.x> <Day Month Year> All versions should have a version number (v.0.x (for draft) or v.x.0 (for final); i.e., v0.1 for the first draft and v.1.0 for the first final version) and a submission date. Use the international date format (day month year) and write out the month (e.g., 23 June 2015). Table of Contents LIST OF ABBREVIATIONS ....................................................................................................................................... v STATEMENT OF COMPLIANCE ............................................................................................................................ vi SCHEMATIC OF STUDY DESIGN ....................................................................................................................... viii 1 KEY ROLES .................................................................................................................................................... 1 2 INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ........................ 1 2.1 Background Information ...................................................................................................................... 1 2.2 Rationale ............................................................................................................................................... 1 2.3 Potential Risks and Benefits .............................................................................................................. 2 2.3.1 Known Potential Risks ..................................................................................................... 2 2.3.2 Known Potential Benefits ................................................................................................ 2 3 OBJECTIVES AND PURPOSE .................................................................................................................... 3 4 STUDY DESIGN AND ENDPOINTS ........................................................................................................... 3 4.1 Description of the Study Design ........................................................................................................ 3 4.2 Study Endpoints ................................................................................................................................... 3 4.2.1 Primary Endpoint .............................................................................................................. 4 4.2.2 Secondary Endpoints ...................................................................................................... 4 4.2.3 Exploratory Endpoints ..................................................................................................... 4 5 STUDY ENROLLMENT AND WITHDRAWAL ........................................................................................... 4 5.1 Participant Inclusion Criteria .............................................................................................................. 5 5.2 Participant Exclusion Criteria ............................................................................................................. 5 5.3 Strategies for Recruitment and Retention ........................................................................................ 6 5.4 Participant Withdrawal or termination ............................................................................................... 7 5.4.1 Reasons for Withdrawal or Termination ....................................................................... 7 5.4.2 Handling of Participant Withdrawals or termination .................................................... 7 5.5 Premature Termination or
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