Get the free CDA INVESTIGATOR AND SPONSOR CONTACT INFORMATION FORM - uab

This form is used to provide contact information for investigators and sponsors involved in research, facilitating efficient negotiations for agreements related to confidentiality and grant administration.

How to fill out cda investigator and sponsor

How to fill out CDA INVESTIGATOR AND SPONSOR CONTACT INFORMATION FORM

1. Obtain the CDA Investigator and Sponsor Contact Information Form from the relevant source.
2. Begin by filling out the investigator section, including the full name of the investigator.
3. Provide the investigator's contact information, including phone number, email address, and institution.
4. Next, complete the sponsor section with the sponsor's full name or company name.
5. Include the sponsor's contact details such as phone number, email address, and address.
6. Review all provided information for accuracy to ensure it meets requirements.
7. Submit the completed form as directed, whether electronically or via postal service.

Who needs CDA INVESTIGATOR AND SPONSOR CONTACT INFORMATION FORM?

1. Researchers conducting clinical trials or studies.
2. Sponsors of clinical trials needing to provide contact information.
3. Regulatory bodies that require information on study contacts for oversight.

People Also Ask about

What are the roles and responsibilities of sponsor and investigator?

Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in ance with the general investigational plan and protocols

What is the role of a sponsor investigator?

Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in ance with the general investigational plan and protocols

How to fill out 1571 form?

Include the following information on Form FDA 1571: Contact information and mailing address of the sponsor (or sponsor-investigator) IND number, if it has been issued. Serial number (see below) The name(s) of the drug/biologic and the indication being studied. The contents of the submission.

What should the sponsor provide to the investigator before entering into an agreement to conduct a trial?

2 Before entering an agreement with an investigator/institution to conduct a trial, the sponsor should provide the investigator(s)/institution(s) with the protocol and an up-to-date Investigator's Brochure, and should provide sufficient time for the investigator/institution to review the protocol and the information

How to fill out a 1572?

Field 1: NAME OF AND ADDRESS OF INVESTIGATOR. Field 2: EDUCATION, TRAINING, AND EXPERIENCE THAT QUALIFY THE INVESTIGATOR AS AN. EXPERT IN THE CLINCIAL INVESTIGATION OF THE DRUG FOR THE USE UNDER INVESTIGATION. Field 3: NAME AND ADDRESS OF ANY MEDICAL SCHOOL, HOSPITAL, OR OTHER RESEARCH.

What are the responsibilities of an investigator?

Investigators are responsible for supervising the proper handling, administration, storage, and destruction of investigational agents (ie, drug accountability). Although these tasks can be delegated to an appropriately qualified individual, the investigator maintains ultimate responsibility.

What is the difference between a sponsor and an 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 a sponsor?

They are responsible for the success of a project and provide necessary guidance and resources to the project team and manager. Ideally, project sponsors provide high project sustainability, strategic planning, and successful implementation of the project's objectives.

For pdfFiller’s FAQs

What is CDA INVESTIGATOR AND SPONSOR CONTACT INFORMATION FORM?

The CDA Investigator and Sponsor Contact Information Form is a document used to collect essential contact details for investigators and sponsors involved in a Clinical Data Agreement (CDA), ensuring clear communication and responsibilities between parties.

Who is required to file CDA INVESTIGATOR AND SPONSOR CONTACT INFORMATION FORM?

Both the investigator and the sponsor involved in the clinical study are required to file the CDA Investigator and Sponsor Contact Information Form.

How to fill out CDA INVESTIGATOR AND SPONSOR CONTACT INFORMATION FORM?

To fill out the CDA Investigator and Sponsor Contact Information Form, provide accurate and complete contact details for both the investigator and the sponsor, including names, phone numbers, email addresses, and institutional affiliations.

What is the purpose of CDA INVESTIGATOR AND SPONSOR CONTACT INFORMATION FORM?

The purpose of the CDA Investigator and Sponsor Contact Information Form is to facilitate effective communication between the investigator and the sponsor, ensuring that both parties can reach each other easily for matters related to the clinical study.

What information must be reported on CDA INVESTIGATOR AND SPONSOR CONTACT INFORMATION FORM?

The form must report information such as the names, titles, institutions, phone numbers, and email addresses of the investigator and sponsor, as well as any additional relevant contact details necessary for collaboration.