Vendor Responsibilities/ Tasks

 

1. Responsibility for Study Documents

  • EudraCT number application
  • Study protocol writing
  • Study protocol approval
  • Study protocol amendments writing
  • Translation of Study protocol summary from English to Bulgarian
  • Informed Consent Form (ICF) writing in Bulgarian
  • ICF translation to English
  • ICF printing
  • Investigator Brochure Development
  • Study products label content approval
  • Translation of Study products label prototype to Bulgarian for submission to Regulatory Authorities
  • eCRF Development 
  • eCRF completion guidelines writing
  • Study specific forms (e.g. source documents template) development, approval and printing

2. Responsibility for Study Set-Up & Initiation

  • Interaction with Competent Authorities 
  • Compilation/submission of documents required for study approval
  • Managing submission fees required by Competent Authorities 
  • Providing SPONSOR with approval by Competent Authorities
  • Contracting insurance for study-site related activities and medical intervention
  • Identifying, selecting, contracting and signing confidential agreements with subcontractors 
  • Analytical Methodology Information Sheet approval
  • Bioanalytical study plan review and approval
  • Bioanalytical report review
  • Obtaining the principal investigator Curriculum Vitae and other relevant credentials
  • Investigators / Staff / Volunteers / Hospital /Clinical Laboratory / Analytical Laboratory Fee Payments
  • Obtaining the Financial Disclosure Agreements   
  • Trial Master File (Site) set-up
  • Randomization list 
  • Investigator meeting – organisation 

3. Responsibility for Study Conduct

  • Conduction of the study according to the Study protocol and the applicable legislation and regulations
  • Subjects’ recruitment, screening and randomization
  • QC of source documents throughout the study
  • QC of data entry in the eCRF
  • Managing biological samples for bioanalytical analysis
  • Ensuring adequate and timely method validation and bioanalytical results reporting 
  • Direct communication with the Analytical Laboratory

4. Responsibility for Handling Study products

  • Study products packaging labelling
  • Study products appropriate storage 
  • Study products administration to study subjects
  • Final Study products reconciliation
  • Returning the Study products to the SPONSOR or destruction after SPONSOR approval 

5. Responsibility for Study Monitoring & Logistics

  • Study monitor selection
  • Conduction of monitoring visits
  • Assuring completeness and accuracy of all source documents/study related records
  • Safety laboratory results clinical assessment
  • Providing SPONSOR with a copy of relevant study documents on an ongoing basis 
  • Providing translation services if necessary for monitoring/audits/inspections
  • Attending SPONSOR and/or SPONSOR’s authorised third parties site audits 
  • Providing appropriate and timely responses to SPONSOR audits, and implementing the corresponding CAPA Plan
  • Maintaining close contact with subcontractors
  • Shipment of samples to the analytical laboratory used in PK samples’ analysis
  • Reporting of SAEs, SUSARs and SARs to SPONSOR, within the required timelines for reporting 
  • Following-up SAEs, SARs and SUSARs 
  • Reconciling SAEs, SUSARs and SARs with SPONSOR’s Clinical Safety person of contact
  • Assisting in reporting SUSARs to the applicable Ethics Committee 
  • Notification of other relevant safety reports (e.g. pregnancy, misuse, and/or abuse) to the RA 
  • Notification of other relevant safety reports (e.g. pregnancy, misuse, and/or abuse) to the EC
  • eCRF completion on an ongoing basis
  • Maintenance of backup copies of completed eCRF forms
  • Maintenance of study documentation and correspondence throughout the study 
  • Data discrepancies resolution 
  • Prepare and deliver to the SPONSOR the Final Clinical Study Report

6. Responsibility for Project Management

  • Project Management and Co-ordination
  • Maintenance of continuous communication (phone, written) 
  • Availability for phone conferences, when required
  • Preparation of the meeting agenda and meeting minutes
  • Conduction of internal project team meetings

7. Responsibility for Data Management

  • Data management plan development and approval
  • Data discrepancies identification and follow-up until appropriate resolution
  • Ensuring the study database is kept updated and the data is reviewed on an ongoing basis
  • Maintaining an audit trail of the data changes in the study database
  • Coding adverse events/concomitant diseases (according to MedDRA) and medications (according to ATC)
  • Preforming SAE reconciliation 
  • Performing database quality control
  • Locking study database

8. Responsibility for Statistics and Clinical Reporting

  • Statistical/pharmacokinetic analysis plan writing and approval
  • SAS programming and validation for tables, figures and listings (TFLs)
  • Ensuring accuracy of study data reported in the TFLs
  • Protocol deviations assessment 
  • Protocol deviations reporting to SPONSOR
  • Protocol deviations classified as Serious Breaches reporting to the Competent Authorities
  • Conduction of final data analysis
  • Draft Clinical Study Report (CSR) writing according to ICH E3
  • Final CSR writing
  • Providing section 2.7.1 with clinical study data ready-to-be used in the submission of the dossier to the RA, according to EMA requirements