Which document provides guidance

The original must be returned to the study sponsor and a copy retained A new FDF must be completed any time there is a change in the investigator's financial situation i. This should include all email correspondence. This works well for medical licenses as well as lab certifications. The training record should reflect appropriate training for all study personnel.

This can include training on specimen collection, handling, and storage. Miscellaneous Documentation Sample of label attached to investigational product containers Instructions for handling investigational product and trial-related materials Shipping records for investigational products and trial-related materials Certificates of analysis of investigational products shipped Decoding procedures for blinded trials Source Documents To document the existence of the subject and substantiate integrity of trial data collected.

This includes information regarding site-specific risk assessments, planning requirements, access, inventory and audits, and barriers.

Suitability Assessment Program Guidance This document provides guidance for developing and implementing the pre-access and ongoing suitability assessment programs for entities that possess or use Tier 1 select agents and toxins.

This includes leadership requirements, access privileges, training requirements, visitor policies, and example interview questions. Guidance on the Inventory of Select Agents and Toxins This document provides information regarding the inventory of select agents and toxins for long term storage, including definitions, storage criteria, and record maintenance.

Guidance on the Transfer of Select Agents and Toxins This document provides guidance on how to safely transfer select agents and toxins in compliance with federal select agent regulations.

Exclusion Guidance This document provides guidance on regulatory exclusions, the exclusion request and review process, and exclusions by federal law enforcement agencies. Guidance on the Inactivation or Removal of Select Agents and Toxins for Future Use This document provides guidance on the requirements for inactivating or removing select agents and toxins for future use.

This includes definitions; the development, validation, and verification of inactivation procedures, and failure reporting requirements. Guidance on the Regulation of Select Agent and Toxin Nucleic Acids This document provides information on the regulation of select agent and toxin nucleic acids, including regulated materials, non-regulated materials, and working with FSAP-regulated genomes at lower containment.

Restricted Experiments Guidance This document includes information regarding examples of potential restricted experiments, restricted experiments requests, and transfers of products resulting from restricted experiments. Access Note-to-file. This template assists the study team in contacting study participants. This template will link the assigned study identification number to the actual patient identity. It can be used to link enrolled participant identity or protected health information to their research data.

This template lists all of the protocol deviations from a particular study. The template may also be used to submit accumulated deviations to the IRB at the time of a continuing review for a study. This template can be used to keep track of protocol training. This log documents and tracks the status of each potential or enrolled participant in a study. Access this log. This template serves to organize a Site Initiation Meeting to guide the content of the meeting in order to ensure the site is prepared for the proper conduct of the study.

Access the tracking log. This log may be used to document the number of participant withdrawals and terminations, as well as the reasons for withdrawal or termination. A participant may withdraw their consent to participate in the study, or the principal investigator may terminate a participant based on safety issues or other factors.

This template can be used to document study-specific conversations with or about a study participant. Access this form. This document provides guidance on communication with your sponsor. Access this document. This document provides guidance on study drug accountability. Services By category. By audience. Stories of Impact. Partner Sites. Contact Contact Us. People Directory.