firstname.lastname@example.org | (512) 243-6426
|Responsible Party||Study Director is single point of contact for the study, with overall responsibility and control of the study and its components. Appointed by Testing Facility Management.||The Study Sponsor takes responsibility for the initiation, management, and financing of a clinical study. The Study Sponsor may transfer any or all of the Sponsor’s trial-related duties and functions to a Contract Research Organization (CRO), but the ultimate responsibility for the quality and integrity of the study always resides with the Sponsor. If a study is conducted by a team of individuals at a trial site or CRO, the Investigator is the responsible leader of the team and may be called the Principal Investigator.||No Study Director assigned or appointed. No single point of contact is required.|
|Quality Assurance Unit or Quality Control Unit Oversight||Quality Assurance Unit inspects critical phases of each study and periodically inspects the facility to inform Testing Facility Management of the integrity of the studies and compliance or non-compliance with the GLPs. Is entirely separate from the personnel engaged in the study. Is oversight function only, not quality system or control.|| The Study Sponsor is responsible for implementing and maintaining quality|
assurance and quality control systems to ensure that studies are conducted and data are generated, documented, and reported in compliance with the protocol, SOPs, and GCPs.
|Quality Control Unit has responsibility and authority to approve or reject all procedures and aspects of testing/manufacturing. Is overall quality system.|
|Study Supervision||Testing Facility Management is responsible for designating a Study Director with appropriate education / training for each study. Ensures there is a Quality Assurance Unit separate from the personnel engaged in the study. Ensures facility, personnel, equipment, etc. is available and complies with the GLPs.||Study Sponsors are responsible for ensuring that a GCP study is adequately supervised. Sponsors or Sponsor-appointed qualified individuals, such as Monitors, ensure that the study is conducted and documented properly. Principal Investigators ensure that participating Sub-Investigators have adequate training and experience to assist in the study.||Supervisors should have proper training. Responsibilities should be in written procedures and followed.|
|Type of Testing Conducted||Open-ended determination of product performance, often for submission to the EPA or FDA for pre-market approval.||Studies that involve the participation of human subjects where data is intended to be submitted to regulatory authorities.||Determination of whether or not the product/sample has met manufacturing specifications.|
|Facility||Design and construction must be suitable to the type of testing conducted, with separation of areas for minimizing mix-ups/contamination. Lighting, plumbing, sewage, washing facility regulations are not mentioned under GLPs.||The testing facility must have adequate facilities available for the foreseen duration of the study. Separation of areas for minimizing mix-ups/contamination is not mentioned under GCPs. Lighting, plumbing, sewage, washing facility regulations are also not mentioned under GCPs.||Design construction must be suitable to the type of testing conducted, with separation of areas for minimizing mix-ups/contamination. Lighting, plumbing, sewage, and washing facility requirements are specified under GMPs.|
|Equipment||Equipment must be appropriate, maintained, and the state of equipment documented to provide study reconstructability. Data-generating equipment is calibrated.||Equipment must be adequate to safely and properly conduct the study||Equipment must be qualified for use in manufacturing processes. Data generating equipment for product testing purposes is calibrated. The accuracy, sensitivity, specificity, and reproducibility of test methods shall be established and documented.|
|Standard Operating Procedure (SOP) /Written Procedure||Drafted by any qualified personnel, approved by Testing Facility Management.||Drafted by any qualified personnel, may be written by the Study Sponsor, Contract Research Organization, or Testing Site.||Drafted by any qualified personnel, approved by Quality Control Unit.|
|Protocol||Each study requires a study-specific protocol indicating study objectives and methods for conduct and is approved by both the Study Sponsor and Study Director prior to initiation. Protocol overrides SOPs.||Each study requires a study-specific protocol indicating study objectives, methodology, statistical considerations, and organization of a study. Protocols must receive approval from Institutional Review Boards (IRBs). The Sponsor approved protocol, or an alternative contract, must be signed by the study Investigator to confirm agreement with conducting the study in compliance with the protocol.||Study-specific protocols are not required. Standard written procedures are followed.|
|Master Schedule||An index of all studies is maintained by the Quality Assurance Unit.||Master Schedule is not addressed.||Master Schedule is not addressed.|
|Records and Reports||Signature or initials of personnel conducting all procedures, preparations, calibrations, etc. are required along with dates completed and must be on all records. Records are maintained in secure archives for at least 5 years following date of registration if used to support a marketing permit or 2 years following study completion/termination. Archivist is responsible for archives and ensures security of documentation.|
The Investigator maintains essential study documents for at least 2 years after the last approval of a marketing application or at least 2 years have elapsed since the discontinuation of clinical development of the product. The Investigator takes measures to prevent accidental or premature destruction of these documents. Upon request of the monitor, auditor, IRB/IEC, or regulatory authority, the Investigator makes available for direct access all requested study-related records.
|Signature of both the personnel conducting procedures and personnel verifying steps of procedures must be on all records (dual control of procedures/records). Records are maintained (not specified in archives) for at least 1 year following product expiration date.|
|CAPA System||Not required.||Not Required.||Required.|