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ICCBS > Dr. Panjwani Center for Molecular Medicine and Drug ResearchSectionsCenter for Bioequivalence Studies and Clinical Research (CBSCR)Departments > Regulatory Department
Regulatory Department
Regulatory and Data Management Department

Regulatory and Data Management( RD) Department of CBSBR is well versed with national and international guidelines and requirements of clinical studies, especially of US-FDA, EMEA and WHO.

The R D Provide regulatory support for assigned clinical research projects by interacting with various departments/ teams to ensure filing of required regulatory documents on schedule as per regulatory forms.

 The Regulatory and Data Management dept. is focused on:


Protocol Writing & Its Approval

Regulatory and Data management department is expert in study protocol writing, processing them through ethical committees and getting approvals from IEC and Ministry of Health Pakistan, WHO, and other international regulatory body.


Investigational Drug Accountability

To maintain records of the delivered, dispensed, consumed investigational drugs at clinical site.


Study Report Compilation

The RD department is responsible for final Report compilation and report writing. The state-of-the-art computing technology and softwares are employed in all mathematical and statistical evaluations used in report generation.


Archiving

The RD department is also responsible for archiving of the study based documents and materials in compliance with all applicable regulatory guidelines.


Protocol and Regulatory Compliance

he RD department oversee all stages of the study for protocol adherence and regulatory compliance.


Archiving Facility

CBSBR have appropriately secure, environmentally-controlled space for the archiving of study related documents i.e. fire protected, water protected. It is under the supervision of regulatory department.

The following guidance, which reflects the requirements ICH Good Clinical Practice, is used to gauge the suitability of an archiving facility in Investigator site premises.


Record Keeping

All the records after the completion of the study including source documents retained for at least 15 years and will be destroyed keeping in consideration the protected health information and also the confidentiality of the organization and human subject in proper manner.


Confidentiality & Security

Access to the archive facility restricted and documented.


Environmental Conditions

Documentation stored in areas with minimal variation in temperature and humidity.

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