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Documents

Guidelines

Guideline on Storage and Distribution of Investigational Products (2011)

Guideline Regarding Independent Data Monitoring Committees (2011)

Guideline Regarding the Principles and the Essentials for Good Clinical Practice of Advanced Therapy Medicinal Products (2011)

Guideline for Preparation of the Reports of Good Clinical Practice Inspection (2011)

Guideline Regarding Application Format for Application to Ministry in Clinical Trials (2011)

Guideline Regarding Application Format for Application to Ethics Committee in Clinical Trials (2011)

Guideline Regarding the Conduct of Good Clinical Practice Inspections Related to Laboratories Participating in Clinical Drug Trials (2011)

Guideline Regarding Collection, Verification, and Submission of the Reports of Adverse Events / Reactions Occurring in Clinical Drug Trials (2011)

Guideline On Site Organization Management Principles In Clinical Drug Trials (2011)

Guideline For Performing Audits Of Good Clinical Practices Related With Phase I Units (2011)

Good Clinical Practices (2011)

Guidance For Conduction Of Good Clinical Practice Inspections Of Sponsor And Contract Research Organization (2011)

Guidance On Ethical Approaches For Clinical Trials Conducted With The Pediatric Population (2011)

Guideline For Observational Studies Conducted On Drugs (2011)

Guidance On Insuring Volunteers In A Clinical Trial (2011)

Guideline for insurance of volunteers for clinical drug trials (2009)

Guideline on Independent Data Monitoring Committees (2010)

Guidance on Ethical Considerations for Clinical Trials on Medicinal Products with the Pediatric Population (2010)

Guidance for the Preparation of Good Clinical Practice Inspection Reports (2010)

Guidance on the Format of Applications to the Ministry for a Clinical Trial (2010)

Guidance on Observational Studies with Drugs (2010)

Guidance On Insuring Subjects In A Clinical Trial (2009)

EC Guidelines on Medical Devices (April 2004)

Guideline for Pharmacovigilance inspections (2009)

Guidance on the collection, verification and presentation of adverse reaction reports occuring during clinical trials (20 April 2009)

Guideline for Good Clinical Practices (2009)

Guideline regarding application format and documentation to be submitted to in an application for ethics committee opinion clinical trials (2009)

Guideline on Compassionate Use Program (2009)

Circular on the Guidance on Observational Studies Conducted with Drugs, 30.12.2008

EC guideline on assessing similarity of medicinal products versus authorised medicinal products (2008)..

EC guideline on review of the period of market exclusivity of orphan medicinal products (2008)..

Guidance on Observational Studies Performed with Drugs in Turkey (May 2008)..

Guidance on Planning, Conducting and Evaluating Observational Studies Performed with Drugs in Turkey (In English)..

Code of Ethical Promotion Practices for Medicinal Products (ARBPC)

Guideline on Requirements for First-in Man Clinical Trials (Draft)

EC SUSAR Database

EC EUDRACT Database

EC Ethics committee submission (2006)

EC Clinical Trials Document (2005)

EC Adverse events guideline (2004)

Clinical Research Association © 2006-2007