Administration of Radioactive Substances Advisory Committee (ARSAC)
The committee that advises the Health Departments on written applications from practitioners for certificates which will enable them to use specific radioactive medicinal products in diagnosis, therapy or research.
An ARSAC research certificate is obtained for all trials which result in radiation exposure to subjects additional to that involved in their routine diagnostic or therapeutic management.
Advanced Therapy Investigational Medicinal Products (ATIMP)Means an ATMP as defined in Article 2(1) of Regulation 1394/2007 which is tested or used in a clinical trial (in accordance with Article 2(d) of Directive 2001/20/EC).
Advanced Therapy Medicinal Products (ATMP)Means any of the following medicinal products for human use: a gene therapy medicinal product a somatic cell therapy medicinal product a tissue engineered product. As defined in Article 2(1) of Regulation 1394/2007.
Adverse Event (AE)Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Adverse Reaction (AR)Any untoward and unintended response to an investigational medicinal product related to any dose administered. Comment: All adverse events judged by either the reporting investigator or the sponsor as having a reasonable causal relationship to a medicinal product would qualify as adverse reactions. The expression ‘reasonable causal relationship’ means to convey, in general, that there is evidence or argument to suggest a causal relationship.
Allocation ConcealmentA technique used to prevent selection bias by concealing the allocation sequence from those assigning participants to intervention groups, until the moment of assignment. Allocation concealment prevents researchers from (unconsciously or otherwise) influencing which participants are assigned to a given intervention group.
AuditA systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analysed and accurately reported according to the protocol, sponsor’s Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
Authorised Health Professional (AHP)In relation to the Chief of Principal investigator in a CTIMP; a registered doctor, dentist, nurse or pharmacist. This definition does not apply for research other than CTIMPs.