Essential Regulatory Documentation

Purpose Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of Good Clinical Practice and all applicable regulatory requirements. Best Practice Considerations Review ICH […]

Documentation of Study Visit Interventions/Observations

Purpose The purpose of source documentation is to reconstruct the research study as it happened. It should allow for data to be confirmed, validated, and support the fundamental principle of protecting the participant’s rights, safety and well-being. These templates are intended to assist in documenting study procedures, interventions, observations, etc. Below are several examples that […]

Documentation of Informed Consent

Purpose These templates are intended to assist in documenting the consent discussion and process with potential participants. There are many ways to document the informed consent process. Below are several examples that can be customized to meet your specific study needs/requirements (study populations, optional items etc.). Best Practice Considerations Documentation of the consent/assent process should […]

Running Note

Investigators and coordinators have found a running note to be an effective way to document interactions with participants. This document should be an ongoing record that is signed and dated as each entry is made. Items noted on this type of document are phone call conversations, items to watch for during the next study visit, […]