Prime Responsibilities Of A Sponsor While Conducting Clinical Trials

The sponsor is the individual or institution that takes responsibility for the initiation, management and financing (or arranging the financing) of the study. The sponsor must satisfy itself that the study meets the relevant standards and ensure that arrangements are put and kept in place for management, monitoring and reporting. The sponsor should implement a system to manage quality throughout all stages of the trial process. The sponsor should ensure that all aspects of the trial are operationally feasible and should avoid unnecessary complexity, procedures, and data collection. Protocols, case report forms, and other operational documents should be clear, concise, and consistent.

#British #BioMedicine #Institute #offers #Skilled #NanoDegree in #Clinical #Trials, #Pharmacovigilance and #Regulatory #Affairs ( #CTPRA)

The specific regional requirements for a clinical study sponsor can vary. Generally, a sponsor is responsible for:

  • The sponsor should identify risks to critical trial processes and data. Risks should be considered at both the system level (e.g., standard operating procedures, computerized systems, personnel) and clinical trial level (e.g., trial design, data collection, informed consent process).
  • The sponsor is responsible for selecting the investigator(s)/institution(s). Each investigator should be qualified by training and experience and should have adequate resources to properly conduct the trial for which the investigator is selected.
  • Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly
  • The sponsor should evaluate the identified risks, against existing risk controls by considering:

(a) The likelihood of errors occurring.

(b) The extent to which such errors would be detectable.

(c) The impact of such errors on human subject protection and reliability of trial results.

#British #BioMedicine #Institute #offers #Skilled #NanoDegree in #Clinical #Trials, #Pharmacovigilance and #Regulatory #Affairs ( #CTPRA)
  • Providing investigator(s) with the necessary information to conduct the clinical trial
  • Agreements, made by the sponsor with the investigator/institution and any other parties involved with the clinical trial, should be in writing, as part of the protocol or in a separate agreement.
  • Ensuring proper monitoring of the clinical study
  • Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor.
  • A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor
  • The sponsor should periodically review risk control measures to ascertain whether the implemented quality management activities remain effective and relevant, taking into account emerging knowledge and experience.
  • Ensuring all the necessary ethic review(s) and approval(s) are obtained
  • The sponsor should describe the quality management approach implemented in the trial and summarize important deviations from the predefined quality tolerance limits and remedial actions taken in the clinical study report
  • The sponsor should designate appropriately qualified medical personnel who will be readily available to advise on trial related medical questions or problems.
  • Preparing and submitting clinical trial application(s) and amendment(s) to the appropriate regulatory agencies
  • The sponsor should utilize qualified individuals (e.g. biostatisticians, clinical pharmacologists, and physicians) as appropriate, throughout all stages of the trial process, from designing the protocol and CRFs and planning the analyses to analyzing and preparing interim and final clinical trial reports.
  • The sponsor is responsible for securing agreement from all involved parties to ensure direct access to all trial related sites, source data/documents , and reports for the purpose of monitoring and auditing by the sponsor, and inspection by domestic and foreign regulatory authorities.
  • The sponsor may consider establishing an independent data-monitoring committee (IDMC) to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.
  • The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s).
  • When using electronic trial data handling and/or remote electronic trial data systems, the sponsor should: (a) Ensure and document that the electronic data processing system(s) conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistent intended performance (i.e. validation).
  • The sponsor should decide which risks to reduce and/or which risks to accept. The approach used to reduce risk to an acceptable level should be proportionate to the significance of the risk.
  • Ensuring that any reviewing ethics board and regulatory agencies are promptly informed of any significant new information (for example, important findings that affect product safety) in a clinical study
  • The sponsor should document quality management activities. The sponsor should communicate quality management activities to those who are involved in or affected by such activities, to facilitate risk review and continual improvement during clinical trial execution.
  • The sponsor should use an unambiguous subject identification code that allows identification of all the data reported for each subject.
  • If the sponsor discontinues the clinical development of an investigational product, the sponsor should notify all the trial investigators/institutions and all the regulatory authorities.
  • The sponsor should inform the investigator(s)/institution(s) in writing of the need for record retention and should notify the investigator(s)/institution(s) in writing when the trial related records are no longer needed.
  • If the sponsor discontinues the clinical development of an investigational product (i.e. for any or all indications, routes of administration, or dosage forms), the sponsor should maintain all sponsor-specific essential documents for at least 2 years after formal discontinuation or in conformance with the applicable regulatory requirement(s)
  • Ensuring compliance with labelling, reporting and record-keeping requirements
  • Refraining from engaging in promotional activities and other prohibited activities such as commercializing an investigational medical device
  • Ensuring that the clinical study is conducted in accordance with Good Clinical Practice (GCP)
  • During protocol development, the sponsor should identify those processes and data that are critical to ensure human subject protection and the reliability of trial results.

British Bio Medicine.

An Evidence and Skilled Based Learning Platform
Close Menu