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This document outlines the sponsor agreement for the Phase 2 pilot study of MDMA-assisted psychotherapy in subjects with chronic, treatment-resistant PTSD. It details the protocol, participant eligibility,

How to fill out doc-035 external protocol signature

How to fill out DOC-03.5 External Protocol Signature Page

1. Obtain the DOC-03.5 External Protocol Signature Page form.
2. Review the instructions provided with the form.
3. Fill in the title of the document at the top of the page.
4. Enter the name of the principal investigator or lead researcher.
5. Provide the names of all co-investigators associated with the protocol.
6. Indicate the date when the protocol was prepared.
7. Sign and date the page as the principal investigator.
8. Ensure all co-investigators sign and date the form as well.
9. Submit the completed form along with the protocol for review.

Who needs DOC-03.5 External Protocol Signature Page?

1. Researchers conducting studies that require external approval.
2. Institutions or organizations submitting proposals to regulatory bodies.
3. Principal investigators and co-investigators involved in research protocols.

People Also Ask about

What is an investigator in ICH GCP?

ing to the ICH Good Clinical Practice guidelines, a protocol should include the following topics: Title Page (General Information) Background Information. Objectives/Purpose.

What is a protocol signature page?

PROTOCOL SIGNATURE PAGE (PSP) The PSP documents the investigator's acknowledgment of receipt, their review of the Protocol, and their agreement to conduct the study ing to its terms.

What is an investigator meeting in clinical research?

Investigator meetings are collaborative events where all investigators involved in a particular clinical trial come together. The primary purpose of these meetings is to ensure that all investigators clearly understand the trial protocol and can perform consistently across multiple sites.

What is the difference between an investigator and a sub investigator?

In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. “Sub-investigator” includes any other individual member of that team (21 CFR 321.3). Sponsor means a person who takes responsibility for and initiates a clinical investigation (21 CFR 312.3).

What are the responsibilities of the investigator?

Investigators are ultimately responsible for the conduct of research. Investigators may delegate tasks to appropriately trained and qualified members of their research team. However, investigators must maintain oversight and retain ultimate responsibility for the conduct of those to whom they delegate responsibilities.

What is an investigator in a clinical trial?

In research, a clinical investigator is a person who is involved in running a clinical trial or research study. The investigator may help prepare and carry out the protocol (plan) for the study, monitor the safety of the study, collect and analyze the data, and report the results of the study.

For pdfFiller’s FAQs

What is DOC-03.5 External Protocol Signature Page?

The DOC-03.5 External Protocol Signature Page is a document used in research protocols that requires signatures from authorized individuals to ensure compliance and approval of the protocol.

Who is required to file DOC-03.5 External Protocol Signature Page?

The DOC-03.5 External Protocol Signature Page must be filed by the principal investigator and any co-investigators or members of the research team who are involved in the study.

How to fill out DOC-03.5 External Protocol Signature Page?

To fill out the DOC-03.5 External Protocol Signature Page, individuals must accurately complete the required fields, including their names, titles, and signatures, ensuring that all necessary parties have signed before submission.

What is the purpose of DOC-03.5 External Protocol Signature Page?

The purpose of the DOC-03.5 External Protocol Signature Page is to document approval and endorsement of the research protocol, confirming that all parties agree with the proposed plan and understand the responsibilities involved.

What information must be reported on DOC-03.5 External Protocol Signature Page?

The DOC-03.5 External Protocol Signature Page must report the names, roles, and signatures of all involved parties, as well as the title of the research protocol and the date of signing.