GCLP Guidelines for Clinical Trials CRO and Bioanalytical Lab

Good Clinical Laboratory Practices (GCLP) is a set of standards embracing both research & clinical aspects developed initially in 2003 by the British Association of Research Quality Assurance for research involving biological systems. Later in 2008, NIH/DAIDS/NIAID expanded the GCLP regulations, and today they are the standards followed by bioanalytical labs and CROs performing clinical trials funded by these organizations.

The GCLP standards are subdivided into the following major categories:

Organization and personnel standards:

It suggests the requirements for documents like personal, organizational, and job policies. Also, it mandates staff educations & evaluations, programs for job introduction, and job-specific training & assessments. The personnel working with clinical trials in CRO and bioanalytical labs need to undergo GCLP training available on the DAIDS portal.

Standards for the use of equipment:

These standards focus on general & equipment specific guidelines and documentation. Temperature monitoring and standards for backup instruments, along with service guidelines of each instrument, should be mentioned and followed strictly as per the specifications of GCLP for this equipment.

Standards for operations in testing:

Under these guidelines, laboratories are expected to write the SOPs (Standard Operating Procedures) according to the format provided by the Clinical and Laboratory Standards Institute (CLSI) and distribute them among all the researchers. The procedural documents must be further retained as per the GCLP section 8.

Testing and quality control standards:

Under this section, the GCLP asks the manager or head of the Clinical CRO or laboratory to set the evaluation criteria for quality control of each step in the clinical trials. Quality control of the procedures and materials must be carried out at regular intervals, and the data collected must be analyzed using methods specified under GCLP.

Validation and verification for test methods:

It mandates the verification & documentation of results of each test and determination of the reportable and normal ranges along with Analytical Measurement Range (AMR) & clinically reportable range of the results.

Standards for reports and records:

These GCLP specifications include rules for tracking, retention, and formatting of the records and reports of the clinical trials. It mandates keeping data integrity. This section contains standards for laboratory assays, result modifications, and archiving the reports.

Standards for using physical facilities:

This section contains standards for cleanliness, environment control, molecular amplification, and emergency power supplies of physical facilities and working areas.

Standards for transportation and management of the specimen:

These standards focus on lab trial testing forms, audits & specimen preparations, analysis, and retention.

Safety standards for personnel:

It is compulsory to maintain evacuation policies and document the safety measures for the staff as per the specifications mentioned in this section. Laboratories must fulfill the requirements like maintenance of Safety Data Sheets, policies, training & incident reporting.

Standards for information on laboratory safety:

These standards ask the labs to perform regular audits and documentation for safety. It asks the labs to provide proper technical support to the researchers and proper preparations to fight any possible hazards in the lab.

Quality management standards:

These standards mandate the internal audits as well as bioanalytical laboratory communication plans during the clinical trials.

Thus, the GCLP standards are a combination of all the regulatory specifications to be followed by any laboratory.