Documentation

• Standard Operating Procedures

• Clinical Research Advisory Committee Standard Operating Procedures
• Standard Operating Procedure Of Ethics Committees

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• Bioequivalance/Bioavailability

• 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)

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• Law/Code

• New Law on Clinical Trials (2011)
• Law on Supporting Research and Development Acitivities (2008)

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• Comparative Data..

• Comparative Data on 10 Regulatory Authority..

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• Reports / Presentations

• Why invest in Turkish Pharmaceutical Industry? (2021)
• Corruption In The Pharmaceutical Sector..
• Clinical Development Success Rates 2006-2015
• Clinical Research in Turkey (pps)..
• National Regulations on Ethics and Research in Turkey
• Patient Rights (ppt)
• Why invest in Turkish Pharmaceutical Industry? (2021)

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• Who-Where?

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• Medical Devices

• 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)

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• International Documents

• WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks
• CIOMS - International ethical guidelines for health-related research involving humans (2016)
• ICH-GCP E6(R2) (2017)
• Helsinki Declaration - Seoul 2008..
• Nuremberg Code

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• Clinical Trial Application Forms

• 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)

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• Publications on Clinical Trials

• Transparency in Clinical Research and Status in Turkey & Middle East
• Evaluation of research ethics committees in Turkey
• Turkey's Position Regarding Clinical Drug Trials
• Clinical Research Association: A Leading Civil Society Organisation in Turkey..
• Transparency in Clinical Research and Status in Turkey & Middle East..
• Footsteps of a New CRO Era in Turkey Driven by Enhancement and Increasing Clinical Trial Activities..
• Orphan Drugs: R&D Challenges with Updates from Turkey and Middle East Countries..
• Clinical Trials Journey of Turkey-Long and Thin Road..
• Patients? Motivation about Clinical Trials: A Local Perspective from Turkey...
• Challenges and Barriers to Academic Cancer Research..
• Turkey's Trial Status
• Turkey’s Position Regarding Clinical Drug Trials
• Getting It Right: Being Smarter about Clinical Trials
• New GCP Rules in Turkey
• Clinical Scientific Research Potentials in Turkey
• Transparency in Clinical Research and Status in Turkey & Middle East

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• How to.....?

• Documents needed for compassionate use..
• How to perform observational studies in Turkey?
• How to submit adverse events to the ethical committees?
• How to apply for device related clinical trials?

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• Health Statistics

• WHO Health Statistics of Turkey

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• Guidelines

• Frascati Manual 2015
• Revised CIOMS Guidelines (2016)
• GMP Guideline Update 2016
• Guidance Relating To Insurance Coverage In Clinical Trials (2013)
• Guidelines For Archiving In Clinical Trials (2013)
• Guideline Regarding Collection, Verification, And Submission Of The Reports Of Adverse Events / Reactions Occurring in Clinical Drug Trials (2013)
• Guideline Regarding Independent Data Monitoring Committees (2013)
• Guideline On Storage And Distribution Of Investigational Products Used In Clinical Trials (2013)
• Guideline On Site Organization Management Principles In Clinical Trials (2013)
• Guidance On The Format Of Applications To The Ministry For A Clinical Trial (2013)
• Guidance On The Format Of Applications To The Ethics Committee (2013)
• Guidance On Ethical Approaches For Clinical Trials Conducted With The Pediatric Population (2013)
• Guideline for Observational Studies Conducted on Drugs (2013)...
• 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 the Conduct of Good Clinical Practice Inspections Related to Laboratories Participating 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 insurance of volunteers for clinical drug trials (2009)
• 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)
• 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 on Compassionate Use Program (2009)
• Circular on the Guidance on Observational Studies Conducted with Drugs, 30.12.2008
• Compassionate Drug Use Program (2006)
• EC guideline on assessing similarity of medicinal products versus authorised medicinal products (2008)..
• Guideline on the planning, conduct and evaluation of observational studies performed with drugs in Turkey (In Turkish)
• EC guideline on review of the period of market exclusivity of orphan medicinal products (2008)..
• 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

•  Guidelines - OUTDATED

• Bylaw on Clinical Research (2013) (English)..
• Guideline on Storage and Distribution of Investigational Products (2011)
• Guideline Regarding Independent Data Monitoring Committees (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 For Observational Studies Conducted On Drugs (2011)
• Guidance On Insuring Volunteers In A Clinical Trial (2011)
• Guidance on Ethical Considerations for Clinical Trials on Medicinal Products with the Pediatric Population (2010)
• Guidance on Observational Studies with Drugs (2010) (old version)
• Guidance On Insuring Subjects In A Clinical Trial (2009)
• Guideline regarding application format and documentation to be submitted to in an application for ethics committee opinion clinical trials (2009)
• 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)..

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• European Directives

• 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

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• Regulations/Bylaws

• 2014 amendment of 2013 GCP Regulation..
• 2013 GCP Regulation..
• Updated Regulation Clinical Trials of Medicinal and Biological Products (2014)..
• Bylaw on The Safety of Medicinal Products (2014)..
• Regulation on Clinical Trials - 08/2011
• 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)

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