Is there any regulatory notification that AV consenting is not required for biologic/biosimilar product?
As per the Gazette notification July 2015, an audio visual (AV) recording of the IC process in case of vulnerable subjects in clinical of new chemical entity or new molecular entity including procedure of providing information to the subject and understanding of his consent shall be maintained by investigator for record.
As per 122DA 2015, (d) “New Chemical Entity” means an active substance in developmental stage which may be specified as a drug under the Act, after undergoing any clinical trial.
As per biosimilar guidelines of CDSCO, biosimilars are new drugs. Hence, AV recording of consent process is required for clinical trials of biosimilars if it includes vulnerable subjects.
Please see ICG GCP definition of vulnerable subjects
1.61 Vulnerable Subjects: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.
What are the retention requirements for investigational medicinal products in clinical trials?
ICH GCP suggests
5.14.5 The sponsor should maintain sufficient quantities of the investigational product(s) used in the clinical trials to reconfirm specifications, should this become necessary, and maintain records of batch sample analyses and characteristics. To the extent stability permits, samples should be retained either until the analyses of the trial data are complete or as required by the applicable regulatory requirement(s), whichever represents the longer retention period.
Drugs and Cosmetics Rules of India recommends the licensee shall maintain reference samples from each batch of the drugs manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the label, the reference samples shall be maintained for a period of three months beyond the date of expiry or potency. In case of drugs where no date of expiry of potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture.
What are the regulations for anti-sera e.g. antiserum for snakebite?
For regulatory purpose, anti-snake venom is considered in the category of vaccines. You have to follow regulations for vaccine/biological.
Is it necessary for a clinical investigator to sign X-ray report prior to entering the findings in Case Report Form?
X-Ray is a part of source documentation. The X-ray should be reported and signed by the radiologist, who is qualified as an expert to review and report radiological investigations. Hence, the physician does not have to sign the X-ray report. He can enter the findings of X-Ray in the CRF
Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:firstname.lastname@example.org