Get the free Submission of Investigator Site-related Study Modifications to CGIRB

Site specific Change Request Form This form may be submitted by Fax (9194654311) or by other electronic means. Please note that changes noted in Sections 1,2,6,8 and 9 require a change to your approved

How to fill out submission of investigator site-related

How to fill out submission of investigator site-related

1. Start by gathering all the necessary documents and information required for the submission.
2. Begin by providing basic information about the investigator site, such as the name, address, and contact details.
3. Next, include information about the Principal Investigator (PI) leading the site, including their qualifications and experience.
4. Specify the research study or clinical trial for which the submission is being made. Include details about the study protocol, objectives, and expected outcomes.
5. Provide an overview of the facilities and resources available at the investigator site, including laboratory equipment, medical supplies, and patient recruitment capabilities.
6. Include information about the site staff, such as their roles and responsibilities, training, and certifications.
7. Outline the procedures and protocols followed by the investigator site in handling study participants and data collection.
8. Include any relevant certifications or accreditations held by the investigator site, such as Good Clinical Practice (GCP) certification.
9. Provide details about the ethical considerations and approvals obtained for the study, including Institutional Review Board (IRB) approvals.
10. Finally, review the completed submission thoroughly for accuracy and completeness before submitting it to the relevant authorities.

Who needs submission of investigator site-related?

1. Pharmaceutical companies conducting clinical trials and research studies require submissions of investigator site-related information.
2. Contract research organizations (CROs) responsible for overseeing clinical trials and ensuring compliance also need this information.
3. Regulatory bodies and ethics committees responsible for approving and monitoring clinical trials require investigator site-related submissions.
4. Academic institutions conducting research studies involving human participants may also require investigator site-related submissions.
5. Investigators and research teams involved in clinical trials need to submit investigator site-related information.

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