Informed Consent and management of Investigational Product

The Informed Consent process is one of the most important aspects of a clinical research study. It is imperative that the Informed Consent form is approved by the ethics committee and where necessary the Regulatory Authorities prior to providing the consent to a potential study subject.

The Informed consent process includes the open exchange of information that occurs between you, the investigator and the potential study subject of a clinical trial.  During this discussion you will review the subject’s responsibilities,  their rights as well as the risks and benefits of their potential participation in the clinical trial.  The subject also needs to be provided with the opportunity to ask you any questions they may have, and to have these questions answered to their complete satisfaction.  Although this process begins at the start of a clinical trial, the responsibility for the process continues throughout the study to ensure that all study subjects remain informed of any updated findings or new information concerning the study drug, study protocol, and their willingness to continue with their participation in the study.

Only when the subject has willingly signed the approved informed consent form, may study-related procedures be initiated. This includes changes to the subject’s current medication, diet or a study required medication washout period.

Now let’s look at the requirements for the storage and handling of investigational product. It is important that investigational products are maintained in a secure area with access only to appropriate study personnel.

If the investigational product is to be physically moved between facilities during the course of the trial, as the investigator you must provide adequate documentation to describe the processes followed to ensure the investigational product is securely and properly stored and accounted for at all times.  As the investigator you are required to document receipt of investigational products from the Supplier.  In addition, you must carefully and accurately document the distribution to and return of investigational product from the study subjects, and then finally, you must document the return of the used and unused investigational product to Supplier.

The investigational product must be stored under the specific conditions outlined in the protocol.  For example, the investigational product may need to be protected from direct light.  It must also be stored in a location where the temperature range is maintained according to the protocol required specifications.  To verify compliance with these requirements, a temperature log must be maintained, documenting the appropriate temperature of the investigational product storage location.

In accordance with ICH-GCP, it is your responsibility to follow the randomization procedures according to the protocol. You must also retain the sponsor-provided masked randomization codes or IVRS authorization code in a secure location for use in the event of a medical emergency. 

Delegated responsibility for handling study drug

These responsibilities  include study drug receipt, storage, and dispensing as well as drug accountability, temperature monitoring and required documentation. Please review the Site Signature & Responsibility Log to ensure this delegation is appropriately captured. The delegation of handling study drug is appropriately documented per guideline 4.6.2 & 4.1.5.