Study director, responsibilities

If the test facility claims to be GLP-compliant but is located in a country where there is no authorised body responsible for GLP monitoring, i.e., a national GLP compliance program, the Study Director needs to be assured that the facility (including the archive, if used) does operate in compliance with GLP principles. This can be achieved by conducting a pre-study QA test site inspection or by a review of documentary evidence, e.g., notice of adverse findings and subsequent responses, or Establishment Inspection reports. The Study Director should ideally discuss the above with QA personnel and send copies of any documentary evidence used to the Quality Assurance Unit (QAU) for inclusion in the QA multi-site study file. 

If the trial is planned through the services of a contract research company, their estimate should include a time and cost accounting which specifies the exact services they will perform for the trial. Services not included are the responsibility of the Study Director and sponsor. When contracting out a field residue study, the contractor s cost estimate will only be a part of the total cost to the sponsor. Make sure that costs... 

To be successful, an LSMBS requires a clear definition of the responsibilities of each participating individual or group. Preparation of an organization chart may be appropriate, as would its inclusion in the study protocol. Key study participants could include Study Directors, Principal Investigators in the sample collection and analytical phases, sponsor representatives, technical consultants, residue analytical laboratories, and QA specialists. 

A Study Director must be appointed, with overall responsibility for the study and for approving the study plan and any amendments to the study. The Study Director has the responsibility to oversee the technical aspects of the study and so must have appropriate qualifications and experience to be able to supervise the work carried out. The Study Director must ensure that the agreed protocols are followed and that any unavoidable deviations from the protocol are justified and fully documented. The Study Director is also responsible for the following ... 

The format of the final report from a study is closely defined and the Study Director is responsible for its production. The test item and name of the study must be clearly identified, along with the start and end date. It has to be accompanied by a statement from the Quality Assurance unit that the study and any critical aspects of the work have been conducted to the requirements of GLP principles. It will contain the names of all those involved with the study and their address this includes the Study Director, the Principal Investigator, and all the scientists... 

Study director The individual responsible for the overall conduct of a (nonclinical laboratory) study. 

Study director means the individual responsible for the overall conduct of the study. Principle investigator means the individual who acts on behalf of the study director in case of multi site studies. Master schedule means a compilation of information to assist in the assessment of the workload and the tracking of studies at a test facility. 

The Study Director is the single point of the study control and has the responsibility for the overall performance of the study and the final report. He or she is the delegated individual from the laboratory management to make sure that the laboratory performs under the GLP principles. His or her responsibilities are shown on this and the next shde. 

Test Facility Organization and Personnel Study Director s Responsibilities... 

Historical control data is an essential component of the study directors toolbox for interpreting reproductive and developmental toxicity data. Scientific judgment and expertise should be used to determine if historical control data is needed for interpretation of study data, which historical control data is appropriate, and how it should be used to support interpretation of a finding. This tool can be a valuable addition to a comprehensive assessment of the study data, which includes determining whether a dose-response is present and whether any statistically significant findings occurred. Sound data interpretation requires that the litter, not the fetus or pup, be used as the experimental unit in developmental and reproductive toxicity studies. For continuous data (e.g., fetal weight). 

The proposed regulations went beyond these basic requirements for a valid study by requiring each study to have a study director who would have ultimate responsibility for implementation of the protocol and conduct of the study [ 3e/31(a)], and each testing facility to have a quality assurance unit to monitor conduct of studies. The concept of a quality assurance unit to monitor study conduct was a new one to most laboratories but a familiar one in manufacturing facilities operating under various GMP regulations. 

Despite making management responsible for many areas that the proposal had assigned to the study director, the... 

For each noncUnical laboratory study, a scientist or other professional of appropriate education, training, and experience, or combination thereof, shall be identified as the study director. The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control. The study director shall assure that... 

The study director is not required to observe every data collection event, but should assure that data are collected as specified by the protocol and the standard operating procedures (SOPs) and that data collection includes the accurate recording of unanticipated responses of the test system. The study director should also review data periodically, or assure that such review occurs, to promote the accurate recording of data and to assure that data are technically correct. 

This section suggests the need for frequent interaction between the study director and QA personnel. Deviations from GLP requirements noted by the QAU must be reported periodically to management and the study director. If those reports indicate that corrective action is stiU needed for any deviation from regulatory requirements, it is the study director s responsibility to assure that corrective action occurs. 

Under 58.33(c) the study director is responsible for documenting all circmnstances that may affect the quahty and integrity of the study. Such circumstances must be described in the final report. 

Similar to the requirements for a study director, a non-clinical testing laboratory must designate a single individual to be responsible for the archives. It is permissible to designate an alternate archivist to serve in the absence of the designated archivist. 

The principles of GLP require an independent quality assurance (QA) program to ensure that the study is being conducted in compliance with GLP. The QA personnel cannot overlap with those of the study because of the potential conflict of interest, but they may be part-time staff if the size of the study does not warrant a full-time QA section. The responsibilities of the QA unit are to maintain copies of plans, standard operating procedures, and in particular the master schedule of the study, and to verily, in writing, that these conform to GLP. The QA unit is responsible for inspections and audits, which must be documented and the results made available to the study director and the principal investigator. The QA unit also signs off on the final report. Any problems discovered or corrective action that is recommended by the unit must be documented and followed up. 

---