文档介绍：PREFACE
This document is the DMID protocol template, which is required for developing DMID-sponsored clinical research protocols. Note that instructions and explanatory text are indicated by italics and should be replaced in your protocol document with appropriate protocol-specific text. Section headings and template text formatted in regular type should be included in your protocol document as provided in the template.
This template attempts to provide a general format applicable to all clinical trials evaluating an investigational product. Where specific examples are provided, they are often from the ine area.
Refer questions regarding use of this protocol template to the appropriate DMID Protocol Champion or Clinical Affairs Specialist.
TITLE
DMID Protocol Number:
DMID Funding Mechanism: (., grant #, contract #)
Pharmaceutical Support Provided by: (if applicable)
Other Identifying Numbers:
IND Sponsor: (if applicable)
Principal Investigator:
DMID Protocol Champion:
DMID Medical Monitor:
DMID Clinical Affairs Specialist:
DMID Regulatory Affairs Specialist: (if applicable)
Draft or Version Number: (see DMID SOP for assigning version numbers)
Day Month Year
(Write out the month and use international date format, ., 23 January 2004)
This template is adapted from the ICH guidance document E6 (Good Clinical Practices), Section 6.
Statement pliance
Provide a statement that the trial will be conducted pliance with the protocol,International Conference on Harmonisation Good Clinical Practice E6 (ICH-GCP) and the applicable regulatory requirements. Use the applicable regulations and requirements depending on study location and sponsor requirements. Examples of requirements that are potentially applicable include:
. Code of Federal Regulations applicable to clinical studies (45 CFR 46 and 21 CFR including parts 50 and 56 concerning informed consent and IRB regulations, if under IND, 21 CFR 312).
Directive 9115071EEC: The Rules Governing Medici