Sanjay Motivaras

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  • in reply to: SUSAR LL to EudraCT when studies in EU closed #43640
    Sanjay Motivaras
    Participant

    The views below are of the PIPA committee and do not represent any particular company.

    According to The rules governing medicinal products in the European Union VOLUME 10 – Guidance documents applying to clinical trials
    CLINICAL TRIALS REGULATION (EU) NO 536/2014 DRAFT
    QUESTIONS & ANSWERS
    VERSION 4.1

    7.31 Question: When do requirements to record and report safety issues start and end for the investigator and the sponsor?
    337. AEs, including SAEs, should be recorded by the sponsor and the investigator from the signature of informed consent to the end of the trial unless otherwise provided for in the protocol.

    Therefore our interpretation would be for reporting to continue until the trial has concluded.

    However, in practice it would be recommended to communicate with the specific authority as to whether a line listings is required and for how long as the expectation may differ between countries.

    in reply to: PV 3rd party agreements #42217
    Sanjay Motivaras
    Participant

    Please note, that the response to your query represents the opinions formed from a consensus of the PIPA Committee, but do not represent their employing companies. These responses are intended as guidance. Please also refer to guidelines and your own company procedures.

     

    If the contracted company is merely performing the search on the relevant databases using a keyword search written by the sponsor company and is not looking at the output from the search for example; merely forwarding the hits to the sponsor to review, then a simple contract should be sufficient allowing for obligations to be in the form of a Master Services Agreement complete with schedule of tasks to be performed. (a MSA with task list?)

    However, if the scope of activities expands in areas such as; company is involved in reviewing the data in order to determine whether the listings contain information relevant for your company, or whether the reports contain safety information (not necessarily containing AE information) or that they are generating the keyword search criteria to be used (and validating these), then an expectation would exist for the company to have a safety agreement in place which covers at a minimum, an adequate quality system in place.

     

    For those companies that are merely performing a literature search and forwarding the output to the sponsor for further evaluation, such as the situation you have highlighted, an audit would be recommended in the form of a desktop based audit (Questionnaire).

    If the company is performing more activities, then an audit may be warranted. 

     

    It is expected, as per GVP module I & IV for due diligence assessments to be performed, in order to provide assurances to PV and the sponsors management that the company is capable of performing the critical PV tasks and that systems are in place to ensure continued working in situations that business activities are affected.

    Audits would generally be in addition to due diligence activities in order to demonstrate that a organisation is fulfilling the tasks as detailed within contractual arrangements.

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