From FDA 21 CFR 312.3 under Definitions and Interpretations: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.3

Sponsor means a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and the employees are investigators.

In the industry, a sponsor is a pharmaceutical, medical device, or a diagnostic company who initiates clinical trial. FDA 21 CFR 312 Subpart D describes the responsibilities of sponsors and investigators. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312&showFR=1&subpartNode=21:5.0.1.1.3.4

Some of the main responsibilities of sponsor include:

• Selecting qualified investigators (sites)
• Providing sites with necessary information needed to properly conduct the trial
• Ensuring proper monitoring of the clinical trial
• Keeping regulatory body and sites informed of any new serious adverse events or risks of the product being evaluated
• Maintaining and retaining necessary records
• Ensuring that the product being evaluated is only being used for only that purpose
• Overseeing the overall conduct of the clinical trial following appropriate regulations

The departments involved in clinical trial conduct at a sponsor company may include:

• Clinical Affairs
• Clinical Operations
• Regulatory Affairs
• Medical Affairs
• Data Management
• Statistical Analysis
• Quality Assurance

Depending on the size of the company, some of the work required in overseeing the clinical trial may be done internally (within the company) or via outside vendor(s) such as through a Contract Research Organization (CRO).

Below are some descriptions of departments involved in clinical trial conduct at a sponsor company.

Clinical Affairs

Clinical Affairs’ role is to identify the value of the product and issues involved in product usage. Clinical affairs’ work may include:

• Researching clinical and economic data for product value reporting
• Implementing health economics and reimbursement strategies from payer (government entity, private organization, or individual patient)
• Work with key opinion leaders within the therapeutic area

Clinical Operations

Clinical Operations’ role is to oversee the design, planning, and management of clinical trials. The work involved for clinical operations may include:

• Developing protocol and investigator brochure
• Overseeing investigator and site selection, site qualification, initiation, and close out
• Investigator and site staff training
• Planning and presenting at investigator meetings
• Creating clinical trial related material (case report form, monitoring plans, study manuals, worksheets, etc.)
• Conducting clinical monitoring activities as needed to ensure compliance with the investigational protocol, good clinical practices and appropriate regulations.
• Overseeing activities performed by the Contract Research Organization (CRO) (If the monitoring work is being outsourced to a CRO)

Regulatory Affairs

Regulatory affairs ensure the appropriate licensing, marketing and legal compliance the products to meet the required regulations. They advise on and coordinate the approval and registration of the products with appropriate regulatory authorities, including:

• Food and Drug Administration (FDA) – United States
• European Medicines Agency – European Union
• Medicines and Healthcare products Regulatory Agency (MHRA) – United Kingdom
• Country specific regulatory body

Some work functions within regulatory affairs may include:

• Collecting, collating and evaluating scientific / clinical trial data from R&D and Clinical Operations
• Developing and writing supporting arguments and explanations for submissions for new product licenses and license renewals
• Create product labels and patient information leaflets
• Advising on regulatory requirements
• Managing regulatory inspections
• Reviewing company practices and providing advice on changes

Medical Affairs

Medical Affairs provide scientific advice for clinical development and post market support. This involves working with medical writing, sales, marketing, and customer service. Medical Affairs officer are usually experts in specific field. They can be doctors, pharmacists, and/or PhDs. Medical Affairs’ work functions may include:

• Providing scientific and medical expertise on products
• Developing strategy to highlight product benefits based on science
• Establish and maintain product information repositories
• Monitoring industry developments to assess competitive activity and identify opportunities

Data Management

Data management develops and manages clinical research databases to ensure data integrity and accuracy. Work functions within data management may include:

• Working with clinical operations to design case report forms (CRFs) to capture necessary variables and data needed
• Designing database and creating plans for data-entry, validation, discrepancy management, medical coding, data extraction, database locking, and data quality assessment
• Participates in external quality assurance and compliance audits

Statistical Analysis

Statistical Analysis combines math, statistics, and science to support the clinical trial design and result analysis. Biostatisticians within Statistical Analysis group perform modeling and calculation to determine sample size and find the best approach to collect the data. They also analyze the collected results and generate tables, figures, and listings (TFLs) to present clinical trial results in easy to understand format. Work functions within statistical analysis may include:

• Supporting the design of protocols and case report forms (CRFs) for soundness of trial design
• Writing statistical methodology section of the protocol
• Developing statistical analysis plan (SAP), programming specifications, and SAS programing for derived dataset and validate TFLs
• Performing statistical analysis and preparing statistical methods and results sections for the clinical study report (CSR)
• Providing statistical interpretation and discussion of clinical trial results

Quality Assurance

Quality assurance ensures that clinical trials are conducted properly following the required regulatory and ethical requirements. Those who perform this function should be separate from clinical operations to ensure proper oversight. Some work functions within quality assurance may include:

• Creating, implementing, and upholding standard operating procedures (SOPs) for clinical trial execution
• Performing analysis and audits of clinical trial operations
• Providing quality-based training (e.g., process, GCPs, compliance, regulatory) as needed
• Ensuring inspection readiness and assist in regulatory authority inspections
• Securing proper storage and archival of required quality assurance-related documentation

Sponsor-Investigator

An individual that both initiates and conducts a clinical trial investigation is a sponsor-investigator. FDA 21 CFR 312.3 defined sponsor-investigator as:

Sponsor-Investigator means an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. The term does not include any person other than an individual. The requirements applicable to a sponsor-investigator under this part include both those applicable to an investigator and a sponsor.

Sponsor-investigator can be an investigator at a clinical site who design and conduct clinical trial for internal purpose. A sponsor-investigator assumes all responsibilities required by both the sponsor and investigator. Responsibilities for sponsor-investigator may include:

• Selection of qualified research staff by training and experience
• Commitment to personally conduct or supervise the investigation
• Selection of study monitor(s) qualified to monitor the progress of the clinical trial
• Maintenance of records showing the receipt, shipment, or other disposition of the investigational drugs and records of participants’ case histories
• Completion of regulatory filings, including submission of amendments, annual and final reports
• Timely submission of adverse events and serious, unexpected adverse experience
• Report any findings from tests in laboratory animals that suggest significant risk for human subjects
• Submit annual report (within 60 days of the anniversary date the IND went into effect)

Further information on FDA requirement for sponsor-investigator can be found in 21 CFR 312 sections:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312

• 21 CFR 312.57 Recordkeeping and record retention
• 21 CFR 312.60 General responsibilities of investigators
• 21 CFR 312.62 Investigator record keeping and record retention
• 21 CFR 312.64 Investigator reports

Picture Credit: Medicine 01, by Taki Steve, flickr

Related pages

1. Clinical Trial Site
2. Contract Research Organization (CRO)
3. Institutional Review Board (IRB) or Ethics Review Committee (ERC)
4. Regulatory Body
5. Site Management Organization (SMO)

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