Sponsor Roles & Responsibilities

Question 1

What does 21 CFR 312 state are the sponsor’s responsibilities in relation to PI and Site Qualifications?

Answer 1

“A sponsor shall select only investigators qualified by training and experience as appropriate experts to investigate the drug.”

Question 2

What are a Sponsor’s General Responsibilities (21 CFR 312)? (9)

Answer 2

• Selecting qualified investigators
• Providing PI’s education needed to conduct the investigation properly
• Ensuring proper monitoring of the trial
• Ensuring that the trial is conducted in accordance with the investigational plan and protocols listed in the IND
• Maintaining an effective IND with respect to the trial
• Ensuring the FDA and all participating investigators are promptly informed of significant new AE’s or risks concerning the drug.
• Control of drugs- a sponsor shall ship investigational new drugs only to investigators participating in the investigation
• Obtaining information:
  Signed 1572
  Curriculum vitae (CV)
  Financial Disclosures
• Selection of monitors- select a monitor qualified by training and experience to monitor the progress of the investigation

Question 3

What responsibilities may the Sponsor transfer to a CRO? (21 CFR 312)

Answer 3

• Sponsor may transfer responsibility for any or all of the obligations set forth in a contract to a “Contract Research Organization” or CRO.
  –Any such transfer shall be described in writing
  –If not all obligations are transferred, the contract is required to describe each obligation being assumed by the CRO.
  -CRO that assumes an obligation of a sponsor shall comply with the specific 21CFR regulations applicable to this obligation and shall be subject to the same regulatory action as a sponsor for failure to comply with any obligation assumed under these regulations. Thus, all references to “sponsor” apply to CRO to the extent that it assumes one or more obligations.

Question 4

Define the role of the Sponsor in clinical research.

Answer 4

The Sponsor is an individual, company, institution, or organization that takes responsibility for the initiation, management, and financing of a clinical trial.

Question 5

What key document does the Sponsor develop and maintain throughout the trial?

Answer 5

The Sponsor is responsible for developing and maintaining the Clinical Trial Protocol, a comprehensive plan outlining the study objectives, design, methodology, and statistical considerations.

Question 6

Explain the Sponsor’s responsibility in selecting qualified investigators.

Answer 6

The Sponsor must select qualified investigators, ensuring they have the appropriate credentials, experience, and facilities to conduct the clinical trial.

Question 7

Describe the Sponsor’s role in obtaining regulatory approvals for a clinical trial.

Answer 7

The Sponsor is responsible for obtaining regulatory approvals from relevant health authorities and Institutional Review Boards (IRBs) or Independent Ethics Committees (IECs) before initiating the trial.

Question 8

What is the purpose of the Investigator’s Brochure, and who is responsible for its development?

Answer 8

The Investigator’s Brochure, providing comprehensive information on the investigational product, is developed and updated by the Sponsor to assist investigators in conducting the trial

Question 9

Explain the Sponsor’s role in monitoring the conduct of a clinical trial.

Answer 9

The Sponsor must monitor the trial’s conduct, ensuring compliance with the protocol, Good Clinical Practice (GCP), and applicable regulatory requirements.

Question 10

Describe the Sponsor’s responsibility regarding the safety of trial subjects.

Answer 10

The Sponsor is responsible for ensuring the safety of trial subjects by promptly informing investigators of relevant safety information and taking necessary actions to protect subjects.

Question 11

What is the Sponsor’s role in managing and analyzing data during a clinical trial?

Answer 11

The Sponsor is responsible for managing and analyzing the trial data, ensuring its accuracy, completeness, and quality.

Question 12

Explain the Sponsor’s role in reporting adverse events during a clinical trial.

Answer 12

The Sponsor must report adverse events to regulatory authorities, investigators, and ethics committees, as required by regulations.

Question 13

What are the Sponsor’s obligations regarding recordkeeping in a clinical trial?

Answer 13

The Sponsor is responsible for maintaining essential documents and records related to the trial in the Trial Master File (TMF) in accordance with regulatory requirements.

Question 14

What is the purpose of the Sponsor’s monitoring visits to clinical trial sites?

Answer 14

Sponsor monitoring visits help verify that trial data is accurate, complete, and in compliance with the protocol and GCP.

Question 15

Explain the Sponsor’s role in providing the Investigational Product to trial sites.

Answer 15

The Sponsor is responsible for providing the investigational product to trial sites, ensuring its proper storage, handling, and dispensing.

Question 16

What actions can the Sponsor take if an investigator fails to meet the protocol or GCP requirements?

Answer 16

The Sponsor has the authority to terminate an investigator’s participation if there are persistent protocol violations or non-compliance with GCP.

Question 17

Describe the Sponsor’s role in preparing for regulatory inspections.

Answer 17

The Sponsor is responsible for preparing and assisting with regulatory inspections, ensuring all relevant documents are readily available and compliant with regulations.

Question 18

What is the Sponsor’s responsibility regarding the disclosure of clinical trial results?

Answer 18

The Sponsor is responsible for disclosing the results of the clinical trial, whether positive or negative, in accordance with regulatory requirements.

Question 19

Explain the Sponsor’s role in the selection and management of Contract Research Organizations (CROs).

Answer 19

The Sponsor may delegate certain trial functions to CROs but remains ultimately responsible for the proper conduct of the trial and the quality of the data.

Question 20

Describe the Sponsor’s role in ensuring the quality of data in a clinical trial.

Answer 20

The Sponsor is responsible for implementing quality control and assurance measures to ensure the accuracy, reliability, and integrity of trial data.

Question 21

What is the Sponsor’s role in ensuring the confidentiality of trial data?

Answer 21

The Sponsor must ensure that appropriate measures are in place to protect the confidentiality of trial data and information.

Question 22

Explain the Sponsor’s role in the development and review of the Clinical Study Report (CSR).

Answer 22

The Sponsor is responsible for developing the CSR, a comprehensive document summarizing the trial design, results, and conclusions, which is submitted to regulatory authorities.

Question 23

What is the Sponsor’s role in ensuring the proper handling of biological samples in a clinical trial?

Answer 23

The Sponsor is responsible for establishing procedures for the proper collection, handling, storage, and analysis of biological samples collected during the trial.

Question 24

Describe the Sponsor’s role in preparing and updating the Investigator’s Brochure.

Answer 24

The Sponsor is responsible for preparing and updating the Investigator’s Brochure to provide investigators with the most current information on the investigational product.

Question 25

What actions can the Sponsor take to ensure subject recruitment and retention?

Answer 25

The Sponsor may provide support for subject recruitment efforts, such as advertising, and implement strategies to enhance subject retention throughout the trial.

Question 26

Explain the role of the Sponsor in managing and resolving protocol deviations.

Answer 26

The Sponsor is responsible for managing and resolving protocol deviations, ensuring that corrective actions are taken to maintain the integrity of the trial.

Question 27

Describe the Sponsor’s role in ensuring the validity and integrity of electronic data capture systems.

Answer 27

The Sponsor is responsible for validating electronic data capture systems used in the trial to ensure the integrity, reliability, and security of trial data.