Labeling study medications/devices

Requisition of study medication/device (including placebo and comparator products, if relevant) must be initiated at an early stage to allow sufficient time to procure the study medications/devices and to prepare the final labeling and packaging, taking into account any special circumstances for blind studies and for import requirements. 

Generally, destruction of returned study medications/devices by the sponsor/CRO may not take place until the final report has been prepared and until there is no further reason to question the accountability of the study medication/device. The actual destruction process must be documented in a manner which clearly details the final disposition of the unused medications/devices and the method of destruction. The information is particularly necessary in case of any query regarding environmental impact. In exceptional circumstances, unused study medications (e.g. cytotoxics, radio-labeled products) may be destroyed at the study site, with appropriate documentation. 

Maintain the security and accountability of clinical study supplies, ensure that medications/devices are labeled properly, maintain records of clinical study medication/device dispensing, including dates, quantity and use by study subjects and return or disposition (as instructed by the sponsor/CRO) after completion or termination of the study Archive all CRFs and documents associated with the study for a minimum of 15 years. Notify the sponsor/CRO of any problems with archiving in potential unusual circumstances, e.g. investigator retires, relocates, dies study subject dies, relocates, etc. 

Compliance with medication/device use (by the study subject) should be assessed in all studies. If supplies are dispensed to subjects for self-administration, methods to assure compliance (e.g., diary cards, instructions on labeling, supervised administration) and methods to check compliance (e.g. tablet counts, plasma/urine assays, diary card review) must be in place. At each study visit, the study subjects should be asked to return all unused supplies and empty containers to the investigator, who will check the supplies for assessment of compliance and store them for return to the sponsor/ CRO. The monitor will review all relevant documents (e.g. source documents, CRTs, medication/ device inventory, dispensing forms) to ensure that the data in the CRFs reflect the subjects compliance with the study medications/devices. 

The preparation of study medications or devices for clinical studies is a time-consuming process and often rate-limiting in initiating the study, particularly with double-blind designs. Requisition, labeling and packaging are some of the important considerations. 

Research has recently turned towards oestrogenic effects, and has proved a controversial subject. Work suggests that the most commonly used phthalates do not produce any effect on human reproductive organs. A European Commission decision in 1990 confirmed that DEHP should not be classified or labelled as a carcinogenic or an irritant substance. Another study examined the possible health risk to humans from DEHP, particularly via its use in medical equipment, and concluded that a cancer risk is unlikely, even in haemodialysis patients, who are most exposed to the chemical. One of the world s leading manufacturers of medical devices, Baxter (which had been widely reported to be abandoning the use of PVC), estimates that acute and chronic exposure to DEHP-plasticized medical products totals 5-7 billion and 1-2 billion patient days, respectively. 

Nowadays, nuclear medicine has become an indispensible section of medical science, and the production of radionuclides and labelled compounds for application in nuclear medicine is an important branch of nuclear and radiochemistry. The development of radionuclide generators made short-lived radionuclides available at any time for medical application. New imaging devices, such as single photon emission tomography (SPET) and positron emission tomography (PET) made it possible to study local biochemical reactions and their kinetics in the living human body. 

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