What is drug accountability?
Drug accountability includes: study drug storage, handling, dispensing, and documentation of administration, return and/or destruction of the drug. A drug accountability process should be initiated for any study that uses study- supplied drug.
What is the purpose of the drug accountability record?
It lists many things about each drug, including the drug name, lot number, expiration date, the amount of drug received, used, returned, or thrown away, and the amount left. Drug Accountability Records help make sure that a clinical trial is done safely and correctly.
Who is responsible for product accountability?
In Scrum, the Product Owner is one person who is accountable for the success of the Product.
What is investigational product accountability?
Investigational product accountability records should document a product “chain of custody” which serves as a tracking document to assure that any member of the research team or outside reviewer can track the investigational product from the time it leaves the sponsor/manufacturer until the time it is used by a subject …
How do you calculate drug accountability?
The PDC is calculated as the number of days with drug on- hand divided by the number of days in the specified time interval. The PDC may be multiplied by 100 to yield a percentage. The numerator of the PDC is not merely a sum of the “days supplied” by all pre- scriptions filled during the period.
What is an IDE FDA?
An approved Investigational Device Exemption (IDE) allows: • an investigational device to be used in a clinical study in order to collect S&E data required to support a Premarket Approval (PMA) application, a Humanitarian Device Exemption (HDE), or a Premarket Notification [510(k)] submission to FDA.
Who is responsible for investigational new drug accountability?
Sponsor
The FDA regulations (21 CFR 312.3) define the “Sponsor” of the IND application as “the person who takes responsibility for and initiates a clinical investigation. The Sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization.
Who is ultimately responsible for investigational product accountability at the site?
the investigator/institution
Responsibility for investigational product(s) accountability at the trial site(s) rests with the investigator/institution. The Investigator is responsible to ensure control of investigational product.
What are ICH-GCP principles?
The ICH-GCP is a harmonised standard that protects the rights, safety and welfare of human subjects, minimises human exposure to investigational products, improves quality of data, speeds up marketing of new drugs and decreases the cost to sponsors and to the public.
How is drug compliance calculated?
The proportion of days covered (PDC) is a measure of patient compliance that has been used with increasing frequency [9–13]. The PDC is calculated as the number of days with drug on- hand divided by the number of days in the specified time interval. The PDC may be multiplied by 100 to yield a percentage.