Study personnel

The responsibilities of study personnel, as defined in the GLP Principles, may be regarded to some extent as truisms. It seems to be clear that personnel involved in a GLP study should be knowledgeable in those parts ofthe Principles of Good Laboratory Practice which are applicable to their involvement in the study -, it is also self-evident that it is their responsibility to comply with 

While it is the Study Director who is ultimately responsible for the quality of the study as a whole, he/she cannot be held responsible for the quality of each and every data point and each and every single record. This is clearly the domain of responsibility of the study personnel, who are are responsible for recording raw data promptly and accurately and in compliance with these Principles of Good Laboratory Practice, and are responsible for the equality of their data . Certainly, these raw data will be scrutinised by the Study Director, who will use them for the preparation of the final study report certainly these raw data will be checked by Quality Assurance for their compliance with the provisions of the GLP Principles. However, data quality cannot be obtained retrospectively by control measures ( quality cannot be controlled into the data ), data have to be recorded in such a way that quality is an intrinsic characteristic of these records. Thus, this responsibility of study personnel for the quality of their data cannot be emphasised strongly enough. 

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Detailed design can proceed when the above items have been considered and agreement has been reached on those important to the study. At this point, the roles and responsibilities of study personnel can be defined, development of commodity collection strategies can proceed, and consideration of measurement and reporting methods can begin. 

Contact with the shoppers was restricted to field phase management study personnel, for two reasons. First, clearly defined lines of communication had to be maintained. Second, in order to ensure that the identity of the stores remained blind (i.e., unknown to everyone downstream from sample collection), in compliance with one of the design criteria, communication with the shoppers had to be restricted. Overall, limiting contact with shoppers to one entity and using modern technology, such as facsimiles and e-mail to facilitate and document communications between shoppers and the collection coordinator, were essential factors in the successful conduct of the sampling phase of the study. 

Each analytical laboratory inspected shipments as they were received, and documented the receipt of the samples and their condition. Any problems were immediately communicated to the appropriate field phase management study personnel to facilitate immediate corrections, such as re-shops required because the wrong commodity had been sampled. 

At this stage in planning, the essential study design information listed below should be determined and a written study plan (i.e., protocol) including these key study details prepared. A formal, pre-approved study plan is required for field soil dissipation studies conducted under Good Laboratory Practice (GLP). A written study plan for non-GLP studies is highly recommended since the document serves as valuable guidance for study personnel. 

Study personnel are responsible for the quality of their data... 

Confidentiality of records, with access limited to study personnel and auditors... 

The study director s role is not simply to react to reports of regulatory deviations from the QAU, but also to play a proactive role to assure that study personnel are aware of GLP requirements and that deviations from those requirements do not occur. 

If SOPs are to provide guidance to study personnel on accepted methods for the conduct of routine study procedures, it follows that they must be readily available to the personnel performing those activities. The SOPs should be available in or near the room in which the activities wiU occur. The requirement for immediately available SOPs is not met if an employee must travel some distance in order to consult the SOP manual. In such a case the employee is more likely to guess, and perhaps guess wrongly, about the proper method for study conduct. 

With the advance in computer technology and the increased use of computer networks, many laboratories are making SOPs available in electronic form via read-only central computer files. Electronic SOPs help ensure that aU personnel are using the current version of an SOP, reduce or eliminate the need for distribution of paper copies of the SOPs, and reduce or eliminate the need for follow-up to ensure that SOP manuals are updated properly. A master, hard copy version of the SOPs that is authorized, signed, and dated by management still must be retained in the archives, and the historical file of SOPs should also contain hard copy versions that have been authorized, signed, and dated by management. Like hard copy SOPs, electronic SOPs must be readily available to study personnel. 

The intent of 58.120 is to provide all study personnel with clear directions as to the objectives of a study and all operations needed to fulfill those objectives, therefore even... 

Docmnentation of protocol changes or revisions and the reason for them is best accomphshed by issuing formal protocol amendments, which must be dated and signed by the study director and should be attached to the front of aU copies of the protocol. Such attachments immediately alerts study personnel to protocol changes and help prevent study personnel from overlooking amendments that are hidden at the back of the protocol. 

Only the names of study personnel need be listed in the report. The signatures required are those of the study director and those individuals described in 58.185(a)(12). A laboratory is permitted some discretion in the listing of names. The names of technicians and animal-care workers need not be listed. The list of names is usually limited to senior scientific or supervisory staff... 

The records and documents required to be maintained by the QAU are also subject to the record retention requirements of 58.195(b). Spokesmen for the FDA have stated on occasion that these QA records should be stored in the archives described in 58.190(b). This is an option that can be considered by the QAU, but there is no stipulated requirement in the GLP regulations for such storage. In fact, it could be argued that the requirement of 58.35(a) for the QA function to be independent of nonclinical laboratory study personnel militates against storage of QA records in the archives. 

Training documentation for study personnel including annual GLP training... 

The facility should ensure that in a multisite study, clear lines of communication exist between the study director, Pis, the QA program, and the study personnel. 

Interface with the Study The phrase, responsibility for the overall conduct of the study and for its report may be interpreted in a broad sense for those studies where the study director may be geographically remote from actual experimental work. With multiple levels of management, study personnel, and QA staff, it is critical that there are clear lines of authority and communication, and assigned responsibilities, so that the study director can effectively carry out GLP responsibilities. This should be documented in writing. 

Were study personnel aware of changes in detector response ... 

Ensure for a multi-site study that clear lines of communication exist between the Study Director, Principal Investigator(s), the Quality Assurance Programme(s) and study personnel. 

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