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Clinical Trial Application for Bioavailability and Bioequivalence Studies (07 May 2009)

Documents To Be Included In the Application File To Be Prepared For The Control Of The Centers Performing Bioavailability And Bioequivalence Studies

Documents required for Firms, which will make their CLINICAL practice of bio-availability, bio-equivalence studies in abroad centers..

Documents required for Firms, which will make their LABORATORY practice of bio-availability, bio-equivalence studies in abroad centers..

Bylaw on Bioavailibility and bioequivalance (1994 - in Turkish)

Notification Form Of The End Of A Clinical Trial To The Ministry And The Ethics Committee

Application Form To Import Investigational Products For Clinical Trial Use

Annual Notification Form To The Ministry And Ethics Committee For A Clinical Trial

Notification Form To Obtain Ministry Approval And Opinion Of The Ethics Committee For A Substantial Amendment To A Clinical Trial

Application Form Of A Clinical Trial For Specialty Thesis and/or Academic Purposes

Ethics Committee Evaluation Form of a Clinical Trial Application

Clinical Trial Budget Form

Clinical Trial Application Form

Biological material Transfer Form (11 May 2009)

Post-marketing adverse event report form (in Turkish)

6 Monthly Progress Report Form (In Turkish)

Severe Adverse Event Reporting Form (In Turkish)

Comparative Data on 10 Regulatory Authority..

Draft guidance for non-commercial clinical trials (2006)

EU Directive 2004/9 on the inspection of GLP

EU Directive 2004/10 on the GLP regulation harmonisation..

[Regulation (EC) No 1901/2006 on medicinal products for pediatric use

EU Directive 2005 28 EC

EU Directive 2001

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)

ICH-GCP

WHO Health Statistics of Turkey

Documents needed for compassionate use..

How to apply for device related clinical trials?

How to perform observational studies in Turkey?

How to submit adverse events to the ethical committees?

Helsinki Declaration - Seoul 2008..

International Compilation of Human Subject Protections - 2008 Update

Nuremberg Code

Law on Supporting Research and Development Acitivities (2008)

EC Guidelines On Medical Devices (April 2004)

For Q&A related to this subject go to..

Classification of Medical Devices

Regulation on Active Implantable Medical Devices (In Turkish - 2007)

Regulation on Invitro Diagnostic Medical Devices (In Turkish -2007)

Regulation on Medical Devices (In Turkish -2007)

Patient Rights (ppt)

Turkey's Trial Status

Turkey’s Position Regarding Clinical Drug Trials

New GCP Rules in Turkey

Clinical Scientific Research Potentials in Turkey

Getting It Right: Being Smarter about Clinical Trials

Regulation on the amendment of Clinical trial regulation (2010)

Headings For Aspects Of A Clinical Trial That Might Require A Substantial Amendment

GCP regulation (2008)

Information and Documents For The Import Of Drugs To Be Used In Clinical Drug Trials and Documents To Be Included In the Application File To Be Prepared For The Control Of The Centers Performing Bioavailability And Bioequivalence Studies

Regulation Regarding the Implementation and Inspection of the Support for Research & Development Activities

Regulation on Licensing for Medicinal Products for Human Use

Regulation on Drug Research in Turkey (1993)

Challenges and Barriers to Academic Cancer Research..

National Regulations on Ethics and Research in Turkey

Clinical Research Advisory Committee Standard Operating Procedures

Standard Operating Procedure Of Ethics Committees

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