The Study Plan

Performance of the study 8.1. Study plan 8.2. Content of the study plan 8.3. Conduct of the study ... 

For each regulatory study, a written plan must exist prior to initiation of the study. The study plan must be approved by dated signature of the Study Director and verified for GLP compliance by QA personnel. 

A detailed description of the test system (crop) should be given in the study plan. Information on the growth stage and development of the crop (especially for the period... 

As a rule, residue trials are conducted only with the formulations or types of formulation proposed for registration or re-registration. Different formulations or mixtures may, however, be used in different countries. The details of the relevant formulation should always be presented in the study plan. 

The samples are identified in the receiving laboratory on arrival on the basis of documentation provided in the shipment and the information supplied in the study plan and chain of custody. Acknowledgement to the field investigator can then be given. 

The location where the study plan, samples of test and reference items, specimens, raw data, and the final report are to be stored. 

The length of data storage must be noted in the Study Plan (as a mle a minimum of 10 years for most of the countries within the EU). This, however, can differ between different countries within the EU. Where multi-site smdies are conducted, me location of study raw data for each site must be specified. One preference is to have all original... 

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 study must be carried out in accordance with the study plan, and all data generated must be recorded promptly and signed or initialled and dated. Any corrections must identify who made the correction, when and why. The original data must remain visible. If any changes have to be made to the study plan, these have to be approved by the Study Director, in conjunction with the customer, and documented. The record has to explain why the change was made and the details of the change. 

It is essential that all data generated and any other records or samples (if possible) are retained so that they are available for inspection at a later date. This means that there must be a secure and properly controlled archive, with an archivist to maintain it. The archive will contain a copy of the Study Plan, quality assurance reports, records of staff including their curriculum vitae (CV) and training records. Access to the archive has to be strictly controlled, and any additions to or withdrawals from the archive must be logged (see also electronic records in Section 9.2.1.8). Such removal or additions can only be undertaken by stated personnel. 

Study means an experiment or set of experiments in which a test item is examined. The study plan defines the objectives and experimental design of the study. 

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... 

Knowledge of the GLP principals Access to the study plan and appropriate SOPs... 

They have access to the study plans and Standard Operating Procedures and all updated versions. QA personnel verify in a documented way the compliance of the study plan with the GLP principles... 

Amendments of the study plan are approved and deviations from this are described, explained and acknowledged. 

Each study is given a unique identification and it is conducted in accordance with the study plan. The analyst that performs the tests has the responsibility to record the laboratory data promptly, accurately and legibly. Any changes in the raw data should be made so as not to obscure the previous entry, should indicate the reason for change and should be dated and signed or initialled by the person making the change. 

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