Clinical trial application document list

 

  • Cover letter in Bulgarian 
  • Application form in xml-format
  • Application form in Bulgarian
  • A confirmation of receipt of a number by the European Database for Clinical Trials (EudraCT)
  • A list of competent authorities and ethics committees outside the territory of the Republic of Bulgaria an application has been submitted to 
  • A list of all planned sites, Principal Investigators and study teams on the territory of the Republic of Bulgaria
  • Copies of scientific advice received from EMEAif applicable 
  • Letter of Intent/ Delegation or Agreement issued by Sponsor for authorisation of "CRO" for conducting the Clinical Trial in Bulgaria
  • Letter of Intent/ Delegation or Agreement issued by "CRO" for authorization of Convex for submitting the application and conducting the CT
  • A document certifying a registration on the territory of the EU issued by a Regulatory Authority, not older than 6 months
  • A document certifying a registration on the territory of the EU issued by a Regulatory Authority of the applicant
  • Declaration which allows an access of the BDA inspectors to a third country and in case of multi-centre clinical trial in the Republic of Bulgaria 
  • Declaration for identity of the contents of the documentation submitted to the RA and the EC
  • Declaration for identity of the contents of the application forms submitted on paper and electronic media to the RA 
  • PIS - ICF (master version in English)
  • A description of procedures for patient enrolment 
  • A description of the procedures for the obtaining of an informed consent by a legal representative, when applicable 
  • An ethical justification in case of the recruitment of subjects that are not capable of giving an informed consent under Art. 98 of the LMPHM   
  • Subject card
  • Advertisement for recruitment of subjects, if applicable
  • Copies of any other information that shall be given to subjects before or during the clinical trial 
  • Final clinical trial protocol with current amendments
  • Synopsis of the Protocol 
  • A scientific evaluation of the study done by an expert in the relevant field, if available
  • An ethical evaluation of the Protocol done by the Principal/Coordinating Investigator when it is not part of the protocol
  • Protocol page signed by the sponsor/sponsor's representative and coordinating Investigator
  • Protocol page signed by the PI of all study sites in Bulgaria
  • Case report form - sample
  • Investigator’s Brochure (IB)
  • Summary of the Product Characteristics for all drugs used in the trial that have marketing authorisation
  • Manufacturing dossier of the Investigational Medicinal Product 
  • Manufacturing Authorization of products that are in the process of development and research 
  • GMP certificate for all IMPs
  • Certificate of analysis (if there are any impurities, not specified in the IMPD)
  • TSE certificate (if applicable)
  • Viral safety certificate (if applicable)
  • Declaration stating that the product originates from a standard batch, is manufactured in compliance with the terms of the marketing authorization
  • A summary of all ongoing studies with the investigational product
  • Samples of the study drug labels
  • A description of the technical equipment necessary and/or the technical requirements for executing the Protocol
  • A declaration confirming the availability of technical equipment in accordance with the Protocol’s requirements 
  • Certificates for participating in an independent quality assessment system/for a successful accreditation procedure of the contracted lab/labs
  • Reference values of the contracted lab/labs for all parameters measured in the course of the study
  • A Curriculum Vitae listing the professional qualifications of the head of the contracted lab/labs
  • Curricula Vitae verifying the education and qualifications of the Principal Investigator
  • Medical Activities Permit/Accreditation, certifying the prerequisites under Art. 87, Par. 1 of the LMPHM
  • Written letter of consent in accordance with Art. 87, Par. 3 of the LMPHM by the Director of the medical institution
  • An insurance certificate “Professional Liability for Clinical Trials” 
  • Agreement template between the sponsor/CRO and the principal investigator
  • Bilingual (EN/BG) Agreement template between the sponsor/CRO and the head of the medical institution
  • A document for a paid fee to RA/EC