Adverse event is an untoward medical occurrence during clinical trial

As per compensation rules, is an adverse event (AE) is mentioned as ‘injury’?  What is the meaning of 'as long as required'?
Nanda Kumari

The definition of SAE in the 122DAB is as follows:
A serious adverse event is an untoward medical occurrence during clinical trial that is associated with death, in patient hospitalization (in case the study was being conducted on out-patient), prolongation of hospitalization (in case the study was being conducted on in-patient), persistent or significant disability or incapacity, a congenital anomaly or birth defect or is otherwise life threatening
As long as required means that the treatment of injury should be continued till the medical person treating the injury feels it is required.

What is the difference between a registry and phase IV studies? Is informed consent required in a registry and phase IV studies?
Neha Mohankumar

3.1.3.4    Phase IV (Variety of Studies: - Therapeutic Use)
Phase IV begins after drug approval. Therapeutic use studies go beyond the prior demonstration of the drug’s safety, efficacy and dose definition.
Studies in phase IV are all studies (other than routine surveillance) performed after drug approval and related to the approved indication. They are studies that were not considered necessary for approval but are often important for optimizing the drug's use. They may be of any type but should have valid scientific objectives. Commonly conducted studies include additional drug-drug interaction, dose-response or safety studies and studies designed to support use under the approved indication, e.g. mortality/morbidity studies, epidemiological studies.

Registry is one type of phase IV study. Registry (Perspectives in Clinical Research 2010 Apr-Jun; 1(2): 57–60) is a prospective observational study of patients with certain shared characteristics (e.g., particular disease, exposure, or risk factor) that collects ongoing and supporting data over time on well-defined outcomes of interest for analysis and reporting. Properly designed and executed, registries can provide a real-world view of clinical practice, patient outcomes, safety, and comparative effectiveness.
Informed consent is required from each patient taking part in phase IV/Registry.

As per the new guidance audio-visual recording of informed consent is applicable to the new subjects to be enrolled in all clinical trials including global clinical trials. Who is considered new subject? Is it fine to ask the name of the volunteer and his volunteer registration number during recording which we do to maintain a track of AV recordings?
Nanda Kumari

All subjects enrolled in clinical trial after the date of CDSCO office order issued on 19 November 2013. AV recording are considered new subjects.
The guideline mentions the following: At the beginning of the video recording process, the Investigator will identify the protocol, the subject/LAR/IW and the language understood by the subject/LAR/IW. In order to identify the subject/LAR/IW his/her photo ID may be documented.

What are the essential contents of a package label for an investigational product to be used in a clinical trial?
Sneha Gupta

In Indian GCP there is a brief outline of label in 2.3.1.6.  Handling of the Product(s). The label should necessarily contain the following information: the words - “For Clinical Studies only”, the name or a code number of the study, name and contact numbers of the investigator, name of the institution, subject’s identification code.
However, EU guidelines provide a comprehensive label for IP ( Ref EudraLex The Rules Governing Medicinal Products in the European Union).Labeling should comply with the requirements of Directive 2003/94/EC. The following information should be included on labels, unless its absence can be justified, e.g. use of a centralized electronic randomization system:
(a) Name, address and telephone number of the sponsor, contract research organization or investigator (the main contact for information on the product, clinical trial and emergency unblinding);
(b) Pharmaceutical dosage form, route of administration, quantity of dosage units, and in the case of open trials, the name/identifier and strength/potency;
(c) The batch and/or code number to identify the contents and packaging operation;
(d) A trial reference code allowing identification of the trial, site, investigator and sponsor if not given elsewhere;
(e) The trial subject identification number/treatment number and where relevant, the visit number;
(f) The name of the investigator (if not included in (a) or (d));
(g) Directions for use (reference may be made to a leaflet or other explanatory document intended for the trial subject or person administering the product);
(h) “For clinical trial use only” or similar wording;
(i) The storage conditions;
(j) Period of use (use-by date, expiry date or re-test date as applicable), in month/year format and in a manner that avoids any ambiguity.
(k) “Keep out of reach of children” except when the product is for use in trials where the product is not taken home by subjects.
This label is acceptable to our regulatory authorities.