Monitoring Planning 2

Monitoring is the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded and reported in accordance with the protocol, SOPs, GCP and applicable regulatory requirements.  The clinical research monitor is the person with direct access to, and oversight of the site research activities. They conduct monitoring visits in accordance with a monitoring plan and provide feedback and training to sites as necessary.    

At the start of the study the monitor should be identified, the site should be qualified by the OCR Regulatory Services team. For industry sponsored trial, a monitor will be provided. For IITs it would be necessary to identify a monitor for the study.  

The monitor is typically part of the Site Initiation Visit (SiV), led by the Regulatory Sponsor for the study. The monitor will then conduct ongoing monitoring, according to the data safety monitoring plan, throughout the trial.  

Investigational Product Management  

The management of an Investigational Product (IP) is a complex and highly regulated activity. The IP may be a drug, biologic, medical device, or combination product; each of which may have unique regulatory and accountability requirements. If the investigator is also serving as the sponsor, additional regulations apply as they are ultimately responsible for accountability of the product.  

Being accountable for the IP includes, but is not limited to, documenting the conditions under which the test article was shipped, stored, administered, returned, and/or destroyed, along with any special labeling or quality control measures that may be required. The research team must also be trained on proper administration of the IP as well as any protocol related requirements for its safe and appropriate use such as randomization and un-blinding procedures. 

At Penn all investigational drugs should be maintained by the Investigational Drug Services. Please consult with them for more information about storage, handling, labeling, dispensing, randomization and unblinding at: Institute for Translational Medicine and Therapeutics - Investigational Drug Service (IDS)