Documentation

Study plans, procedures, and activities shall be documented in writing to assure data quality, integrity, authenticity, and reproducibility. Research institutions shall, therefore, establish and maintain procedures to control all documents that prescribe how studies and experiments are to be conducted and describe how studies and experiments were conducted. Documents can be divided into two broad classes:

• Prescriptive documents that give specific instructions on how a study or experiment is to be conducted (e.g., standard operating procedures [SOPs]).
• Descriptive records that describe what was actually done and what happened during the course of a study or an experiment (e.g., data, reports, lab books, publications).

Document control and approval. Research institutions must establish procedures for the control of prescriptive and descriptive documents. Procedures must include a formal review, approval, and distribution policy such that only the most recent approved documents are available for staff use. In addition, such procedures must include the following:

• Document changes. The research institution shall establish and maintain a change control process for impact, repeatability, approval, traceability, and implementation. Training must be documented.
• Document storage. Documents shall be stored in a secure and suitable environment that provides confidentiality and prevention from loss, deterioration, and destruction. Retention times shall be established and, if applicable, be in compliance with appropriate laws and regulations.

Training. Training of personnel is critical to develop and maintain competence. All personnel should be made aware of the importance of training and its impact on the quality objectives. Research institution management shall ensure that staff assigned to perform research activities have the appropriate combination of education, experience, and training to be competent with their assignments.

Facility and infrastructure. The research institution shall have facilities and equipment sufficient for the conduct of the study and to maintain the infrastructure. Infrastructure includes buildings and workspace, utilities, storage areas, computer and communications networking, and safety equipment.

Test equipment. Test equipment shall be designed, located, and maintained to suit its intended purpose and meet good practices, cleaning, calibration, and validation.

Test methods and method validation. Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled. Validation of methods used in a research institution is critical for the integrity and authenticity of study results.

Sampling and chain of custody. Adequate and correct sampling is critical for ensuring that the sample taken is a true representative of the whole. The research institution shall, therefore, have a sampling plan and procedures for collecting samples of substances, materials, or products for subsequent testing.