GB/T 22275 "Requirements for the Implementation of Good Laboratory Practice" is divided into 7 parts, and this part is Part 7 of GB/T 22275. This part of GB/T 22275 specifies the management and control of multi-site studies, quality assurance, master schedules, research plans, implementation of studies, reporting of research results, standard operating procedures, storage and preservation of records and materials. Except for explicit exemptions from national legislation, the good laboratory practice principles (hereinafter referred to as GLP principles) specified in this part apply to all non-clinical health and environmental safety studies required by regulations, including the registration or application for licenses for pharmaceuticals, pesticides, food additives and feed additives, cosmetics, veterinary drugs and similar products, as well as industrial chemical management. GB/T 22275.7-2008 Requirements for the implementation of good laboratory practice Part 7: Application of good laboratory practice principles in the organization and management of multi-site studies GB/T22275.7-2008 standard download decompression password: www.bzxz.net
GB/T 22275 "Requirements for the implementation of good laboratory practice" is divided into 7 parts, this part is Part 7 of GB/T 22275. This part of GB/T 22275 specifies the management and control of multi-site studies, quality assurance, master schedule, study plan, implementation of studies, reporting of study results, standard operating procedures, storage and preservation of records and materials. Except for explicit exemptions from national legislation, the good laboratory practice principles (hereinafter referred to as GLP principles) specified in this part apply to all non-clinical health and environmental safety studies required by regulations, including the registration or application for licenses for pharmaceuticals, pesticides, food additives and feed additives, cosmetics, veterinary drugs and similar products, and industrial chemical management.
class="f14" style="padding-top:10px; padding-left:12px; padding-bottom:10px;"> GB/T22275 "Implementation Requirements for Good Laboratory Practice" is divided into 7 parts:
---Part 1: Quality Assurance and Good Laboratory Practice;
---Part 2: Tasks and Responsibilities of Project Leaders in Good Laboratory Practice Studies;
---Part 3: Compliance of Laboratory Suppliers with Good Laboratory Practice Principles;
---Part 4: Application of Good Laboratory Practice Principles in Field Studies;
---Part 5: Application of Good Laboratory Practice Principles in Short-term Studies;
---Part 6: Application of Good Laboratory Practice Principles in Computerized Systems;
---Part 7: Application of Good Laboratory Practice Principles in the Organization and Management of Multi-site Studies.
This part is Part 7 of GB/T22275.
This part is equivalent to the Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) Principles and Conformity Monitoring Series Document No. 13: "Application of GLP Principles in the Organization and Management of Multi-site Studies" [ENV/JM/MONO (2002) 9].
This part has been edited as follows:
--- Delete the content of the OECD introduction, preface, and preface related to the convening of each session and the catalogue.
This part was proposed and coordinated by the National Technical Committee for the Management of Dangerous Chemicals (SAC/TC251).
The drafting unit of this part: Shandong Entry-Exit Inspection and Quarantine Bureau.
The main drafters of this part: Wan Min, Che Lidong, Wang Huiyong, Wang Jingtang, Wang Xiaobing.
The provisions in the following documents become the provisions of this part through reference in this part of GB/T 22275. For dated references, all subsequent amendments (excluding errata) or revisions are not applicable to this part. However, parties to agreements based on this part are encouraged to investigate whether the latest versions of these documents can be used. For undated references, the latest versions apply to this part.
GB/T22275.4 Implementation requirements for good laboratory practice Part 4: Application of good laboratory practice principles in field research
GB/T22278 Principles of good laboratory practice

ICS 03. 120. 20
National Standard of the People's Republic of China
GB/T22275.7—2008
Requirements of conducti for Good Laboratory Practice(GLP)-Part 7 :The application of the GLP principles to the organisation and management ofmulti-site studies
2008-08-04 Issued by
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of China
Digital Protection
2009-04-01 Implementation
GB/T22275 "Requirements for the Implementation of Good Laboratory Practice" is divided into 7 parts: Part 1: Quality Assurance and Good Laboratory Practice; Part 2: Tasks and Responsibilities of the Project Leader in Good Laboratory Practice Research; Part 3: Compliance of Laboratory Suppliers with Good Laboratory Practice Principles; Part 4: Application of Good Laboratory Practice Principles in Field Research; Part 5, Application of Good Laboratory Practice Principles in Short-term Research; Part 6: Application of Good Laboratory Practice Principles in Computerized Systems; Part 7: Application of Good Laboratory Practice Principles in the Organization and Management of Multi-site Research. This part is Part 7 of GB/T 22275, GB/T 22275. 7--2008
This part is equivalent to the Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) Principles and Conformity Monitoring Series Document No. 13: "Application of GLP Principles in the Organization and Management of Multi-site Studies" [ENV/JM/MONO (2002) 9]. This part has been edited as follows:
Delete the contents of the OECD introduction, introduction, preface and the contents of the conferences held. This part was proposed and managed by the National Technical Committee for Standardization of Dangerous Chemicals Management (SAC/TC251). The drafting unit of this part: Shandong Exit-Entry Inspection and Quarantine Bureau. The main drafters of this part: Wan Min, Che Lidong, Wang Huiyong, Wang Jingtang, Wang Xiaobing. 1 Scope
Good Laboratory Practice Implementation Requirements Part 7: GB/T22275.7—2008
Application of Good Laboratory Practice Principles in the Organization and Management of Multi-site Studies
This part of CB/T22275 specifies the management and control, quality assurance, master schedule, study plan, study implementation, reporting of study results, standard operating procedures, storage and preservation of records and materials for multi-site studies. Except for explicit exemptions from national legislation, the good laboratory practice principles (hereinafter referred to as GLP principles) specified in this part apply to all non-clinical health and environmental safety studies required by regulations, including registration or licensing of pharmaceuticals, pesticides, food additives and feed additives, cosmetics, veterinary drugs and similar products, and industrial chemical management. 2 Normative References
The provisions in the following documents become the provisions of this part through reference in this part of GB/T22275. For dated references, all subsequent amendments (excluding errata) or revisions are not applicable to this part, however, parties to agreements based on this part are encouraged to investigate whether the latest versions of these documents can be used. For undated references, the latest versions apply to this part.
GB/T 22275.4 Implementation requirements for good laboratory practice Part 4: Application of good laboratory practice principles to field studies GB/T 22278 Principles of good laboratory practice
3 Terms and definitions
Terms and definitions in G3/T 22278 apply to this part. 4 Main technical specifications
4.1 Description of multi-site studies
4.1.1 The planning, implementation, supervision, recording, reporting and archiving of multi-site studies raise a number of potential issues that should be addressed to ensure that GLP principles are not compromised. The fact that different research activities are carried out at different sites means that the planning, communication and control of the study are very important.
4.1.2 Although a multi-site study will consist of work performed at multiple sites (including the test organization and all test sites), a multi-site study is a single study that should be conducted in accordance with GLP principles. This means that there should be a single plan, a single project leader, and a single final report. When initially planning the study, personnel and management at each participating site should be aware that the work they are performing is only part of the study under the control of the project leader and should not be conducted as a separate study. 4.1.3 It is necessary that the work performed by each site be clearly described in the initial stages of planning. This allows the relevant parties to agree on control measures before the study plan is finalized. 4.1.4 Many of the problems associated with conducting a multi-site study can be avoided through clear allocation of responsibilities and effective communication between the parties involved in the study execution. The parties involved include the sponsor, project leader, management, project representative, quality assurance and research staff at each site.
4.1.5 All relevant parties should be aware that when a multi-site study is conducted in multiple countries, additional problems may arise due to differences in national culture, language, and GLP compliance monitoring procedures. In such cases, it may be necessary to seek advice from the GLP compliance oversight authority in your country.
4.1.6 The guidance contained in this part should be considered in the planning, conduct, monitoring, recording, reporting and archiving of multi-site studies. 4.2 Management and Control of Multi-Site Studies
4.2.1 A multi-site study is a study in which phases of the study are conducted at more than one test site. A multi-site study is required when multiple sites that are spatially separated, organizationally different or otherwise separate are required. A multi-site study may include when one department of an organization serves as the test site and another department of the same organization serves as a test site for the former department in a multi-site study. 4.2.2 A phase is a defined activity or series of activities in the conduct of a study. 4.2.3 The decision to conduct a multi-site study should be made by the sponsor in consultation with the test site manager (appointed by the sponsor before the study is initiated) and after careful consideration. The use of multiple sites increases the complexity of study design and management tasks and introduces additional risks that may affect the integrity of the study. Therefore, it is important to assess all potential threats to the integrity of the study posed by multiple sites, clarify responsibilities, and minimize risks. The opinions of technical experts/scientific experts, GLP compliance status, resources, and economic conditions of all possible test sites should also be fully considered.
4.2.4 Communication in Multi-Site Studies
4.2.4.1 In order for a multi-site study to proceed smoothly, each participant involved in the study must be clear about their responsibilities. In order to fulfill these responsibilities and deal with any problems that may need to be solved during the study, it is very important to maintain information and effective communication between the client, site managers, project leaders, project representatives, quality assurance personnel, and researchers. 4.2.4.2 The parties involved should reach an agreement in advance on the communication method of research information and keep it in record. 4.2.4.3 The project leader should keep abreast of the research progress of all sites. 4.2.5 Management of Multi-Site Studies
4.2.5.1 The client will assign a study to a test institution. The site manager will appoint the project leader, who need not be based at the site where the majority of the study work is to be completed. The decision to conduct study activities at other sites is normally made by the site manager in consultation with the project leader and, if necessary, the client. 4.2.5.2 When the project leader is unable to perform his or her duties at a particular site because of geographic or organizational separation, it is necessary to appoint a project representative at that site. Inability to perform duties may be due to travel time, time zones, or translation delays. Geographic separation may be related to distance or the need to be present at multiple sites simultaneously. 4.2.5.3 The site manager should promote the establishment of a good working relationship with the site managers to ensure the integrity of the study. Preferences of the different participating teams or commercial and confidentiality agreements should not prevent the communication of information necessary to ensure the proper conduct of the study. 4.2.6 Roles and responsibilities of personnel
4.2.6.1 Sponsor
Before the study is initiated, the sponsor should consult with the site manager and make a careful decision to conduct a multi-site study. The sponsor should specify whether the study complies with GLP principles and whether it complies with relevant national legal requirements. The sponsor should understand that only one final report can be generated for a multi-site study. b) The sponsor should be aware that if its site is used as a site to undertake part of the multi-site study, its operation and study-related personnel will be subject to the supervision of the project manager. In special circumstances, this may include visits by the site manager, the project leader and/or the quality assurance manager. The project leader must explain the extent to which the study (including any work performed by the sponsor) complies with GLP principles.
4.2.6.2 Site Manager
The site manager should approve the selection of the site. Issues that the site manager should consider include, but are not limited to, the operability of communication, the adequacy of quality assurance arrangements, and the availability of appropriate equipment and technology. The site manager should appoint a quality assurance manager to have overall responsibility for quality assurance throughout the study. The site manager should inform the quality assurance department of all study sites of the location of the head of quality assurance. If it is necessary to use a site that is not covered by the national GLP compliance monitoring program, the reasons for this choice should be documented. The site manager should make it clear to the site managers that the site may be inspected by the national GLP compliance monitoring authority. If there is no GLP compliance monitoring authority in the country where the study is being submitted, the site may be inspected by the GLP compliance monitoring authority in the country where the study is being submitted.
4.2.6.3 Site Manager
The site manager is responsible for providing adequate site resources and for designating a suitably qualified project representative. If it is necessary to replace the project representative, the site manager should appoint a new project representative in consultation with the sponsor, the project leader and the site manager (as necessary) and should provide details to the project leader in a timely manner so that changes to the study plan can be issued. The new project representative should assess the GLP compliance of the study work being replaced.
4.2.6.4 Project Manager
a) The Project Manager shall ensure that the selected trial site is acceptable. This may be achieved by visiting the trial site and interviewing the trial site personnel.
b) If the Project Manager considers that he or she is able to directly and fully control the work of a trial site without having to appoint a project representative, the Project Manager shall advise the trial facility manager of this feasibility. The trial site manager shall ensure that appropriate quality assurance oversight is arranged at this trial site. This may be carried out by the trial site's own quality assurance personnel or the quality assurance manager.
c) The Project Manager is responsible for the approval of the study plan, including the compilation of contributions from the project representative. The Project Manager will approve and issue amendments to the study plan and identify deviations from the study plan, including those related to the work undertaken by the individual sites. The Project Manager is responsible for ensuring that all personnel are aware of the requirements of the study and that the study plan and its amendments are available to all relevant personnel.
d) The Project Manager shall establish, test and maintain an appropriate communication system with each project representative. For example: carefully confirm telephone numbers and email addresses through contact tests, consider signal strength in rural areas, etc. Time zone differences should also be taken into account. The project leader should communicate directly with each project representative and not through an intermediary unless there are unavoidable reasons (such as the need for a translator). The project leader should be easily accessible to the project representative throughout the execution of the study. The project leader should facilitate the coordination and scheduling of events, the transfer of samples, specimens or data between sites, and ensure that the project representative understands each aspect of the custody procedure. The project leader should communicate with the project representative as necessary to the quality assurance aspects of the study site. The project leader's communication with the project representative or the quality assurance staff of the study site regarding these findings should be recorded. The project leader should ensure that the final report is prepared to include any contributions from the project representative. The project leader should ensure that the final report is submitted to the quality assurance director for review. The project leader is responsible for signing and date the final report, indicating responsibility for the validity of the data and the extent to which the study complies with the principles of GLP. This is based in part on written assurances from the project representative.
h) For sites that do not have a designated Project Representative, the Project Director communicates directly with the personnel performing the work, who should be listed in the study plan.
4. 2.6,5 Project Representativewww.bzxz.net
a) For the study phase assigned by the Project Sponsor, the Project Representative shall perform the duties on behalf of the Project Director and shall be responsible for ensuring that the GLP principles are followed during this phase of the study. A fully cooperative and open working relationship between the Project Representative and the Project Director is essential.
b) The Project Representative shall sign a written agreement to undertake the assigned study phase in accordance with the study plan and GLP principles. The signature of the Project Representative on the study plan shall constitute an acceptable agreement. e) Deviations from the study plan or standard operating procedures shall be recorded at the site and confirmed by the Project Representative, and shall be reported to the Project Director in a timely manner and confirmed by the Project Director. d) The Project Representative shall provide the Project Director with relevant documents so that the Project Sponsor can prepare the final report based on the documents. These3
GB/T22275.7—2008
documents should include a written assurance from the project representative that the work they are responsible for complies with the GLP source principles. e) The project representative should ensure that all data and samples for which they are responsible are submitted to the project leader or archived as specified in the study plan. If these data and samples are not submitted to the project leader, the project representative should inform the project leader of the time and place of archiving. During the study, the project representative should not dispose of any samples without the prior written permission of the project leader. 4.2.6.6 Researchers
All professional and technical personnel involved in a study should have a job description and a record of training, qualifications and experience to demonstrate their ability to undertake the assigned tasks. When researchers are required to follow approved standard operating procedures from another test site, any required additional training should be recorded. In some workplaces, there may be temporary personnel to conduct certain aspects of the research. When these personnel derive or record original data, or carry out activities related to the study, records of their qualifications, training and experience should be retained. When these personnel are performing routine activities (e.g., sexual animal management) under the supervision of a more qualified individual, it is not necessary to keep these records. 4.3 Quality Assurance
Quality Assurance for multi-site studies should be carefully planned and organized to ensure that the GIP principles are fully followed in multi-site studies. Multiple management organizations and quality assurance programs may present problems due to the presence of multiple sites. 4.3.1 Responsibilities of the Quality Assurance Manager
4.3.1.1 The Quality Assurance Manager should communicate with the quality assurance personnel at the trial site to ensure that adequate quality assurance checks are implemented throughout the study.
4.3.1.2 Special attention should be paid to the operation and record keeping of communication between the various trial sites. Each trial site should determine the responsibilities for quality assurance activities before the start of the trial.
4.3.1.3 The Quality Assurance Manager will ensure that the study plan has been verified and the final report has been checked for compliance with the GIP principles. Quality assurance checks on the final report should include confirmation that the final report correctly summarizes the project representative's manuscript (including the site's quality assurance certificate). The Head of Quality Assurance will ensure that the quality assurance statement prepared addresses the work undertaken by the test organization and includes or references the quality assurance statements of all test sites.
4.3.2 Responsibilities of Test Site Quality Assurance Personnel 4.3.2.1 Each test site manager is generally responsible for ensuring that appropriate quality assurance is provided for the studies performed at their respective sites. The quality assurance personnel of the test site shall review the parts of the study plan that are relevant to the research activities conducted at the test site. They shall retain copies of the approved study plan and any amendments thereto.
4.3.2.2 Unless otherwise required by the Head of Quality Assurance, the quality assurance personnel of each test site shall check the relevant research work of the site in accordance with the standard operating procedures of their respective sites and report the results of the inspection in writing promptly to the project representative, the test site manager, the project leader, the test site manager and the Head of Quality Assurance. 4.3.2.3 The quality assurance personnel of each test site shall check the project representative's contributions to the study in accordance with the standard operating procedures of their respective sites and provide information related to the quality assurance activities of the test site. 4.4 Master Schedule
4.4.1 For multi-site studies where one or more Project Representatives have been appointed, all sites involved should be identified on the Master Schedule. It is the responsibility of the Facility Manager and/or Site Manager to ensure that this is done. 4.4.2 The study should be uniquely identified on the Master Schedule for each site, with reference to the site identifier as necessary. The Project Leader should be listed on the Master Schedule and the relevant Project Representative should be listed on the Master Schedule for each site. The start and completion dates for the relevant study phases undertaken by all sites should be listed on their respective Master Schedules. 4.5 Study Plan
4.5.1 For each multi-site study, there should be a single study plan. The study plan should clearly state the names and addresses of all sites involved.
4.5.2 The study plan should also include the name and address of each Project Representative and the phases for which they are responsible. It is recommended that the study plan contain sufficient information (e.g. telephone number) to allow the project leader to contact the project representative directly. 4.5.3 The study plan should state how the data generated at the test site for the final report will be provided to the project leader for the completion of the final report.
4.5.4 Where known, it is useful to describe in the study plan where the data, test samples, reference materials and specimens generated at different test sites are kept (if known). 4.5.5 When preparing a draft study plan, it is recommended that the project representative be consulted in order to review and confirm their ability to undertake the work assigned to them. If required, they can provide professional technical advice on the study plan. 4.5.6 Normally, the study plan should be written in a single language, generally the language used by the project leader. For multinational joint studies, it may be necessary for the study plan to be published in multiple languages; this should be indicated in the original and translated versions of the study plan, and the original language should be indicated in all versions. A mechanism should be established to verify the correctness and completeness of the translation of the study plan. The responsibility for the correctness of the translation can be delegated by the project leader to a language expert and recorded. 4.6 Conduct of the study
This clause will restate the most important requirements of ISO 22278 and the recommendations in ISO 22275.4 to provide useful guidance for the organization of multi-site studies. The details of these documents will be discussed further. 4.6.1 Facilities
4.6.1.1 During the study, the test site may not have full-time personnel on site. In this case, additional measures should be taken to maintain the physical security of test samples, specimens and data. 4.6.1.2 When it is necessary to transfer data and materials between test sites, a mechanism should be established to maintain the integrity of these data or materials. Special attention should be paid when data is transferred by electronic means (e-mail, Internet, etc.). 4.6.2 Equipment
4.6.2.1 The equipment used in the study should meet the requirements of the intended month, including the large and high-precision equipment used by some test sites. 4.6.2.2 Equipment should have maintenance and calibration records to demonstrate that the equipment is fit for its intended purpose when used. Some equipment (e.g., rented large animal measuring equipment, analytical equipment) may not have records of regular inspection, cleaning, maintenance, or calibration. In such cases, this information should be recorded in the original data for the specific study to verify that the equipment is fit for its intended purpose. 4.6.3 Control and Responsibility for Research Materials
4.6.3. Procedures should be in place to ensure timely delivery of research-related materials to each site. Maintaining the integrity/stability of materials during transport is critical, so reliable delivery and chain of custody records should be used, and detailed delivery procedures and clear assignment of responsibilities should be established.
4.6.3.2 Each shipment of research materials should be accompanied by sufficient documentation to satisfy any applicable legal requirements (e.g., customs, health and safety laws). These documents should also provide sufficient relevant information to ensure that they are fit for their intended purpose when they arrive at any site, and these documents should be prepared prior to shipment.
4.6.3.3 When study materials are transported as part of a single shipment between sites, proper separation and identification should be performed to avoid mix-ups and cross-contamination of materials. This is particularly important when materials from multiple studies are being transported together. 4.6.3.4 If materials may be adversely affected by environmental conditions during transport, procedures should be established to maintain their integrity. Monitoring can be used to confirm that the required environmental conditions are maintained. 4.6.3.5 The storage, return, and disposal of excess test samples and reference materials used at the site should be noted. 4.7 Reporting of Study Results
4.7.1 A final report should be produced for each multi-site study. The final report should include data from all phases of the study. The project representative provides a signed and dated report of the phase for which he or she was responsible for the summary of the final report. If such a report is prepared, it should include evidence that appropriate quality assurance monitoring has been carried out at the site and sufficient notes to enable the project sponsor to prepare a well-founded final report covering the entire study. Alternatively, the project representative may submit raw data to the project sponsor and the project director should ensure that these data appear in the final report. The final report prepared in this way should clearly identify the project representative and the stage of the study for which he or she was responsible. 4.7.2 The project representative should state the extent to which the work he or she was responsible for conformed to the principles of GLP and provide evidence of the quality assurance work carried out by the site, which will be incorporated directly into the final report, or the relevant details will be extracted and included in the project director's statement of conformity and quality assurance statement in the final report. The extracted details should be cited and retained. 4.7.3 The project director should sign and date the final report, indicating responsibility for the validity of all the data. The extent of conformity with the principles of GLP and specific references to the statement of conformity with OECD GLP and related regulations should be indicated. The statement of conformity should cover all phases of the study and be consistent with the information provided in the statement by the project representative. Any site that does not comply with the principles of GLP should be stated in the final report.
4.7.4 The final report should identify the storage location of the study plan, retained samples of test samples and reference materials, specimens, raw data and final report. The report completed by the project representative should provide information on the retention of materials for which he is responsible. 4.7.5 Only the project leader can modify the final report. When a phase of the study needs to be modified at any site, the project leader should contact the project representative and agree on appropriate corrective actions, which should be recorded in detail. 4.7.6 When the project representative prepares the report, the requirements of the report should be consistent with the requirements of the final report. 4.8 Standard Operating Procedures (SOPs)
4.8.1 GLP principles require the development and adherence to appropriate and technically effective standard operating procedures. The following are examples of standard operating procedures specific to multi-site studies:
a) Selection and monitoring of test sites:
Appointment and replacement of project representatives!
c) the transfer of data, sample holders and specimens between sites, the validation or approval of translations of study plans or standard operating procedures; and d)
e) the storage, return or disposal of study samples and reference materials used at remote study sites. 4.8.2 GLP principles require that standard operating procedures should be readily available to researchers performing research activities, regardless of where they are working.
4.8.3 It is recommended that study site personnel follow the study site's standard operating procedures. If they are required to follow other procedures specified by the project sponsor (e.g., standard operating procedures provided by the study site manager), this requirement should be stated in the study plan. The project representative has the responsibility to ensure that: the study site personnel are aware of the procedures to be followed and have access to the appropriate documentation. 4.8.4 When study site personnel are required to follow standard operating procedures provided by the study site manager, it is necessary for the study site manager to give written approval.
4.8.5 When a standard operating procedure provided by the test agency is issued and implemented at the test site, the test agency manager shall ensure that any subsequent versions of the standard operating procedure that appear during the study are passed on to the test site and that old versions are no longer used. The project representative shall ensure that all personnel at the test site are aware of the changes to the standard operating procedure and that only the current version is used. 4.8.6 When the test site follows the standard operating procedure provided by the test agency, it may be necessary to translate the standard operating procedure into other languages. In this case, it is very necessary to thoroughly check the various translated versions to ensure that the instructions and content are consistent. The language used in the original version should be indicated in the translated version.
4.9 Storage and Preservation of Records and Materials
4.9.1 Attention should be paid to the temporary storage of materials in multi-site studies. Such storage equipment should be secure and able to protect the integrity of the content. When the storage of data is separated from the test organization, it is necessary to ensure that the test site has the ability to access data that may need to be reviewed. 4.9.2 Records and materials need to be stored in accordance with GLP principles. When the storage facilities of the test site cannot meet GLP requirements, the records and materials should be transferred to an archiving agency that complies with GIP principles. 4.9.3 The test site manager should ensure that there are sufficient records to confirm the research in which the test site participated. G
GB/T 22275. 7-2008
National Standard of the People's Republic of China
Requirements for the implementation of good laboratory practice Part 7: Application of good laboratory practice principles to the organization and management of multi-site studies
GB/T 22275. 7—2008
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