Table 1. Quality management system elements and their scores on the good clinical and laboratory practice (GCLP) accreditation checklist.

Source: Stiles et al., 2003.

GCLP Elements	Total points
Section 1: Documents, records and reports	30
Section 2: Trial samples and management	14
Section 3: Organization and personnel	22
Section 4: Reporting of results	10
Section 5: Equipment, materials and reagents	33
Section 6: Internal audits and corrective action	15
Section 7: Retention and archiving of records	32
Section 8: Quality control and external quality assessment	21
Section 9: Planning of the work & sub-contracting	17
Section 10: Conduct of work	24
Section 11: Confidentiality, blinding and patient safety	12
Section 12: Facilities and safety	40
TOTAL	270