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Source data includes info in original records, certified copies of findings

Wednesday, May 5, 2021, 08:00 Hrs  [IST]

Is there a minimum shelf-life that is required for investigational drugs and placebo in clinical trial in India?
Ashish Chavda

New Drugs and Clinical trials Rules 2019 recommend:
•    Stability testing is to be performed to provide evidence on how the quality of a drug substance or formulation varies with time under the influence of various environmental factors such as temperature, humidity, and light, and to establish shelf life for the formulation and recommended storage conditions.
•    Stability studies should include testing of those attributes of the drug substance that are susceptible to change during storage and are likely to influence quality, safety, or efficacy.
•    The stability studies for drug substances should be conducted either in the same container - closure system as proposed for storage and distribution or in a container - closure system that simulates the proposed final packaging.
•    Study conditions should be as storage requirements a) stored under general conditions b) stored in a refrigerator c) stored in a freezer
•    For trial Clinical Trials of New Drugs for details are required as per Table 1 Item 2.6 as per clause 5 of Second Schedule).
•    When the application is for clinical trials only, the international non-proprietary name (INN) or generic name, drug category, dosage form and data supporting stability in the intended container-closure system for the duration of the clinical trial (information covered in item numbers 2.1, 2.3, 2.6, 2.7) are required.

What are the regulatory expectations of source data?
Nandini Salian
Source data, as defined in ICH GCP 1.51, includes all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Recent focus of regulators is on electronic source data.

European Medicines Agency has following observations/ recommendations
•    During GCP inspections, it is frequently seen that data are recorded in multiple locations at a site. It is therefore essential to the possibility of reconstructing the clinical trial that it is clear, where the original record is documented.
•    A detailed diagram and description of the transmission of electronic data should be provided in the protocol. The source data and their respective capture methods should be clearly defined prior to subject recruitment (i.e., in the protocol or in a trial specific source data agreement). The sponsor should describe which data will be transferred, the origin and destination of the data, the parties with access to the transferred data, the timing of the transfer and any actions that may be triggered by real-time review of those data.
•    The investigators should be aware about the location of the source data and consistent in recording them. The intended location should be clearly defined prior to subject recruitment. The site should prepare a source data location list, which should be signed and dated by the principal investigator or by a person whom the principal investigator has assigned this task. The list should be filed in the investigator's trial master file.
•    To facilitate location of data, the list of source data should be sufficiently detailed. All documents included as medical records should be specifically listed e.g., 'patient record – dispensing and administration chart', 'medical record – continuation', 'medical record – nurses notes', etc.

How does one document eligibility of clinical trial participants in source documents?
Dr Prakash Guru

Regulatory inspectors expectations of document eligibility of clinical trial participants are as follows:
•    GCP audits and inspections have reported that source data showed that the subject did not fulfil all eligibility criteria. Often there is no documentation that an investigator/sub-investigator has reviewed all criteria prior to inclusion.
•    Adherence to all individual inclusion and exclusion criteria originating from different sources e.g.  blood samples, physical examination, medical history, information from the subject etc should be documented in the source data.
•    When designing the protocol and the related CRF, the sponsor should carefully consider where each source data originates from, with reference to a specific visit. The sponsor and the investigator should agree about how adherence to the individual criteria would be documented.
•    A qualified physician who is an investigator or a sub-investigator for the trial should assess each individual eligibility criteria and decide to include the participants in the trial. This decision should be documented prior to the subject receiving the first dose of the IMP.


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