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This document is a registry form for investigative sites interested in working with Clinical Device Group Inc. It collects information about the site and investigators for clinical research services

How to fill out investigative site registry

How to fill out Investigative Site Registry

1. Begin by obtaining the Investigative Site Registry form from the relevant agency or organization.
2. Fill in the site name, address, and contact information.
3. Provide details about the principal investigator, including their qualifications and contact information.
4. List the specific studies or clinical trials that the site will be involved in.
5. Indicate the availability of necessary resources and facilities at the site.
6. Review the filled form for accuracy and completeness.
7. Submit the completed form to the necessary authority as per their guidelines.

Who needs Investigative Site Registry?

1. Researchers who are conducting clinical trials.
2. Investigative sites participating in research studies.
3. Regulatory agencies assessing site compliance and capabilities.
4. Sponsors and funding organizations requiring site registration.

People Also Ask about

What is a principal investigator site?

Who is the 'Principal Investigator' (PI)? This may be the chief investigator, or where the research involves more than one site, the principal investigator is the person at each site responsible for the day to day running of the research project.

What is an investigator site?

An Investigator Site File (ISF) contains essential documents which shows that the clinical trial site and Investigator are following the regulatory requirements set out by the ICH GCP guidelines.

What does ISF stand for in medical?

The Sensitivity Factor (ISF) is sometimes also called the correction factor. It reflects the power of a unit of in the body. The ISF indicates how much 1 unit of rapid-acting may drop a blood glucose level (BGL).

Is ISRCTN free?

The ISRCTN registry is not funded by an overall government grant and is not the result of legislation. To ensure that clinical study information is listed freely, a fee is charged for the publication of the information describing a study at inception.

What is an investigative site?

Investigative Sites. Clinical investigative site networks, defined as a group of independent clinical sites based upon specific qualification criteria that function as one entity, may be a new option for offsetting the increase in R&D costs. The networks may differ within and between therapeutic areas.

What is the difference between trial master file and investigator site file?

The investigator site file contains records of a trial at a specific clinical research site. The trial master file records the entire trial across all participating sites. The investigator site file includes all activities, procedures, adherence to regulations and study protocol.

Where does an investigative site maintain essential documents?

Where should Essential Documents be Stored? Essential documents should be stored in an electronic or paper-based site master file. Records regarding the location of the essential documents should be maintained by the sponsor and the investigator/institution.

What is ictrp?

The International Clinical Trials Registry Platform (ICTRP) is a network of registries established by the World Health Organization (WHO) to ensure that they meet specific criteria for content, quality and validity, accessibility, unique identification, technical capacity, and administration.

For pdfFiller’s FAQs

What is Investigative Site Registry?

The Investigative Site Registry is a database that collects and maintains information about sites conducting clinical research.

Who is required to file Investigative Site Registry?

Organizations and individuals conducting clinical trials, including sponsors and investigators, are required to file the Investigative Site Registry.

How to fill out Investigative Site Registry?

To fill out the Investigative Site Registry, applicants need to provide specific site details, including contact information, type of studies conducted, and investigator credentials.

What is the purpose of Investigative Site Registry?

The purpose of the Investigative Site Registry is to enhance transparency and accountability in clinical research by ensuring that sites are officially documented and compliant with regulatory standards.

What information must be reported on Investigative Site Registry?

Information that must be reported includes site name, location, investigator details, type of research conducted, and relevant certifications or approvals.