Description
The purpose of this document is to suggest a uniform system for writing study protocols and to provide a list of essential items that should be included in a study protocol.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
1drug or biological product not yet approved for marketing; Drugs used for treatment use under expanded access categories.; Drug used for treatment under expanded access; The product being provided through expanded access; Drugs provided under expanded access.
Stakeholders
4Responsible for qualifications, training, and trial conduct; Individual responsible for trial conduct and data governance at a site.; May delegate tasks but retains overall responsibility; Person responsible for the conduct of the clinical trial at a trial site; Responsible for trial conduct and participant safety; Responsible for trial conduct, data integrity, and investigational product management.; Individual responsible for trial conduct at a site and informing the institution.; maintaining
Format may be used to prepare final reports by study monitors.; Training and experience of monitor
Veterinarian responsible for selecting anesthetic regimens and conducting field studies
Entity responsible for submitting applications under section 524B
Regulatory Context
Document Types
6Standard Operating Procedures must identify circumstances of potential plasma dilution.
CPME Material Safety Data Sheet reference
Forms for retention of source data
Provisions for Owner Consent if applicable
Submission of results from a completed study or clinical trial
Document defining the design and conduct of the trial
Attributes
6Effect of exposure to humidity (normal or exaggerated conditions)
drug's stability characteristics in the proposed storage environment
Required information for RLD/RS and proposed products.; Product characteristic in ANDA background
Criteria for excluding test animals.
Criteria for selecting test animals.
Description of test animals (e.g., Lactating, Pregnant, Estrus).
Technical Details
Substances
2Component of a similar pharmaceutical VMP.
Diet formulations including feedstuffs and additives.
Testing Methods
4Analyst derives a standard curve to verify linear response.
Define statistical methodology, including hypothesis to be tested
The specification sheet should provide a list of tests, the acceptance criteria for each test, and analytical methods
Allocation of animals to treatment groups.
Processes
3Procedure where worms are identified and counted for effectiveness calculations.
Guideline for protocols for target animal safety trials.
Guideline for protocols for clinical effectiveness trials.
Clinical Concepts
1Safety requirement for the intended animal species
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- CVM GFI #13 Evaluation of Effectiveness of New Animal Drugs for Use in Free-Choice Feeds-Medicated Block
- CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species
- CVM GFI #234 Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications
- CVM GFI #224 (VICH GL52) Bioequivalence: Blood Level Bioequivalence Study
- CVM GFI #213 New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209
- CVM GFI #262 Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices
- FDA's Strategy on Antimicrobial Resistance - Questions and Answers
- CVM GFI #5 Drug Stability Guidelines