ACRC SOPs

Avicenna Clinical Research CEnter

ACRC SOPs

All clinical research studies conducted by Avicenna Clinical Research Centre are carried out according to International Conference on Harmonization (ICH) /Good Clinical Practice (GCP) standards, DRAP, NBC and all applicable laws in Pakistan. The following SOPs are developed for the administration of clinical research to the highest international standards:

Non-compliance to SOP- Procedure for Corrective Action
Investigator’s Responsibilities
Clinical Research Staff Selection and Qualifications
Prior to Initiation of the Study
Investigator’s File, Including Storage and Retention
Institutional Review Board
Screening and Recruitment of Study Subjects
The Informed Consent Process
Completion and Correction of Case Report Forms
Protocol Compliance
Adverse Event Recording and Reporting
Serious Adverse Event Recording and Reporting
Study Testing Procedures
Source Data and Documents
Study Drug Storage and Accountability
Premature Termination or Suspension of a Study

Progress Reports
Study Correspondence
Study Monitoring
DRAP Inspection
Site Compliance Training
Study Close-Out
Device Studies
Temperature Monitoring
Natural Disasters & Hurricanes
Protocol for Emergency Treatment of Patients/Subjects in Distress
Confirmation of Identity of Patients Seen in the Office
Electronic Medical Records- Source Data
Waste Management
Equipment Maintenance / Calibration
SOP Emergency Services – Ready Reckoner
SOP Procurement of Medical Equipment

ACRC SOPs

ACRC SOPs

Avicenna Clinical Research CEnter

ACRC SOPs

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