Study Director and Principal Investigator

It might be added here, that these responsibilities will certainly be transferred to their full extent to an eventual replacement Study Director. Since a permanent replacement will entail the privilege - or the burden, whichever describes the situation better - of accepting, with the signature under the statement of GLP compliance of the final report, the full responsibility for the quality, integrity and reliability of the data and the report, it will be one of the first activities of this person to assure him- or herself, as soon as practicable after taking over the new position, and preferably with the assistance of Quality Assurance personnel, of the GLP compliance in the study as it has been conducted to date. If this were to be done by means of an interim review or data audit, the results of such a GLP review should be fully documented, especially in such cases where deficiencies or deviations were found. 

Besides these scientific aspects of the Study Director s responsibilities, there are a number of more managerial responsibilities, which are, however, as important for the proper conduct of a study as are the scientific principles involved. Already before any work on the study is undertaken, the Study Director should ascertain that management have committed adequate resources to perform the study, and that adequate test materials and test systems are available. In other words, a Study Director should never take on the assignment for the conduct of a study, for which there are no adequate resources. It would therefore certainly lie in the Study Director s responsibility to alert the test facility management about any such deficiencies and to insist on their remediation, as it would, vice versa, become the responsibility of test facility management to react to such an alert with proper measures. 

To conduct a GLP compliant study means that there are requirements for documentation and recording, activities for which the personnel has to expend time and efforts, and any inadequacy in resource allocation would therefore negatively affect the proper and GLP compliant conduct of a study. In the same way the supplying with copies of the study plan of all key person- 

In connection with the actual, experimental conduct of the study, it is the responsibility of the Study Director to ensure that all raw data generated are fully documented and recorded in compliance with the GLP Principles. For data recorded manually this entails ensuring that the data have been recorded promptly and accurately and in compliance with these Principles of Good Laboratory Practice if data are recorded electronically through the utilisation of a computerised system, the Study Director should ensure that (the) computerised systems used in the study have been validated , and are fit for use in the study. 

Compliance with regulations is also the responsibility of the Study Director. In this role the Study Director is responsible for ensuring that the study is carried out in accordance with the Principles of GLP, which require the Study Director s signature on the final study report to confirm compliance with the GLP Principles. And, finally, after the end of the study, the study Director is still responsible for ensuring that after completion (including termination) ofthe study, the study plan, the final report, raw data and supporting material are archived . 

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Closely related to the question of the relative positions of Study Director and Principal Investigator, is the extension of the definition for the location where the study is being performed. 

The Principles of GLP require Quality Assurance to prepare and sign a statement, to be included with the final report, which specifies types of inspections and their dates, including the phase(s) of the study inspected, and the dates inspection results were reported to management and the Study Director and Principal Investigator(s), if applicable . Thus, after having audited the final report of the study, and after having been satisfied with the way the raw data have been recorded and represented in the final report. Quality Assurance has to look at its own records to identify the respective activities performed in connection with the study in question. Quality Assurance has then to draw up a list of such activities with their dates and to include this list in the Quality Assurance statement. 

One further component has to be taken into consideration, when dealing with computerised systems, namely the nature and extent of the communication system between several computers or between computers and peripheral components. It has to be recognised that all communication links, on whatever level, are potential sources of error, and faulty transmission of data may result in their loss or corruption. This is true of personal communication links, e.g. between Study Director and Principal Investigator, but in the case of communication links between and within computer systems the problem may appear... 

Applications to and harvest of major crops such as coffee, bananas, and pineapples frequently involve procedures and equipment for which standard operating procedures have not been written. These must be identified in the planning stage, so that the Study Director or Principal Investigator can write these procedures with sufficient time to allow for review and approval. If a procedure is specific to the trial at hand, the process may be described in an addition or amendment to the protocol, but this still requires QA and management approval. In some cases, SOPs specific to a local crop are maintained at a regional site. SOPs must also be available at the site at which the raw data are archived. 

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... 

The prime players in a GLP scenario would be the management, the sponsor, the study director, the principal investigator, and the QA. 

While it lies in the responsibility of Study Directors (or Principal Investigators) to react to such reports and to take corrective action if necessary, and while it lies in the responsibility of management to ensure that they actually will implement the full corrections required by these Quality Assurance reports, it is nevertheless in the well understood self-interest of... 

A quality assurance program statement listing the types of inspections made and their dates, including the phases inspected, and the dates when any inspection results were reported to management, to the Study Director, and to any Principal Investigators, if applicable. This statement would also serve to confirm that the final report reflects the raw data. 

Appropriate and valid SOP s are established and follovired A Quality Assurance Program is in place A Study Director and a Principal Investigator, If needed, Is designated Documented approval of the study plan The study plan Is available to quality assurance personnel... 

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. 

Name and address of the principal investigator(s) and the phase(s) of the study delegated by the study director and under the responsibility of the principal investigator(s). 

The very same responsibilities are applicable for the case, where the management has to appoint, in addition to the Study Director, also one (or more) Principal Investigator(s). Of course, here is a distinction to be made The management which appoints the Study Director can only appoint Principal Investigators in its own test facilities or test sites. When study parts are out-sourced to an independent GRO, the management of this GRO consequently becomes responsible for the nomination of the respective people. The management of the test facility, where the Study Director is located, is then, however, responsible for ascertaining that there are clear lines of communication between the Study Director and the Principal Invest -... 

First of all, the sponsor should be knowledgeable in the requirements of the GLP Principles. Since the connections between sponsor and study will be mainly through the test facility management and the Study Director, and/or the Principal Investigator, the sponsor should be aware of their responsibilities towards the study, and especially of the fact that the full responsibility for the whole study remains with the Study Director, including the validity of the raw data and the report, notwithstanding any elements of the study which may or may not have been disclosed to the Study Director, as they have been obtained at the sponsor s own test facilities. 

Principal Investigator means an individual who, for a multi-site study, acts on behalf of the Study Director and has defined responsibility for delegated phases of the study. The Study Director s responsibility for the overall conduct of the study cannot be delegated to the Principal Investigator(s) this includes approval of the study plan and its amendments, approval of the final report, and ensuring that all applicable Principles of Good Laboratory Practice are followed. 

Study personnel will have access to the study plan and appropriate Standard Operating Procedures applicable to their involvement in the study. It is their responsibility to comply with the instructions given in these documents. Any deviation from these instructions should be documented and communicated directly to the Study Director, and/or if appropriate, the Principal Investigator(s). 

Deviations from Standard Operating Procedures related to the study should be documented and should be acknowledged by the Study Director and the Principal Investigator(s), as applicable. 

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