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Form FDA 1572 is the statement of Investigator; ?No investigator may participate in an investigation until he/she provides the sponsor with a completed, signed Statement of Investigator, Form FDA 1572 (21 CFR 312.53(c)).? This form is arguably one of, if not, the most important document pertaining to regulatory and ...

Trading Window closure period under Clause 4 of Schedule B read with Regulation 9 of SEBI (Prohibition of Insider Trading) Regulations, 2015 (?PIT Regulations?) ? Extending framework for restricting trading by Designated Persons (?DPs?) by freezing PAN at security level to all listed companies in a phased manner.

The reports document the findings of the monitor, usually a written report to the sponsor after each site visit or other trial-related communication. A monitoring log can document visits to the site, and may be used to track all outside visitors who review the study.

In terms of Regulation 9 of the Listing Regulations, for the purpose of preservation, the documents under the policy are to be classified as: Documents to be preserved permanently. Documents to be preserved for a period of not less than 8 years.

Regulatory Documents means, with respect to a Person, all forms, reports, registration statements, schedules and other documents filed, or required to be filed by such Person with any Governmental Authority or pursuant to any Applicable Law.

Regulatory Documents Investigator's Brochure (IB) ... FDA Form 1572. ... Delegation of Responsibilities Log. ... Protocol and Amendments. ... Information Given to a Study Participant. ... Financial Disclosure Form (FDF) ... Master Clinical Trial Agreement (MCTA) ... IRB Approval.

The Form FDA 1572, otherwise known as the Statement of Investigator, is one of the most important documents in a clinical trial because it shows the sponsor that the PI (principal investigator) will comply with all FDA regulations.