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:

Citing Medicine, 2nd 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
Thank you for using www.freepdfconvert.com service!

Only two pages are converted. Please Sign Up to convert all pages.

https://www.freepdfconvert.com/membership