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1. Responsibility for Study Documents
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- EudraCT number application
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- Study protocol amendments writing
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- Translation of Study protocol summary from English to Bulgarian
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- Informed Consent Form (ICF) writing in Bulgarian
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- ICF translation to English
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- Investigator Brochure Development
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- Study products label content approval
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- Translation of Study products label prototype to Bulgarian for submission to Regulatory Authorities
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- eCRF completion guidelines writing
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- Study specific forms (e.g. source documents template) development, approval and printing
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2. Responsibility for Study Set-Up & Initiation
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- Interaction with Competent Authorities
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- Compilation/submission of documents required for study approval
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- Managing submission fees required by Competent Authorities
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- Providing SPONSOR with approval by Competent Authorities
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- Contracting insurance for study-site related activities and medical intervention
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- Identifying, selecting, contracting and signing confidential agreements with subcontractors
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- Analytical Methodology Information Sheet approval
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- Bioanalytical study plan review and approval
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- Bioanalytical report review
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- Obtaining the principal investigator Curriculum Vitae and other relevant credentials
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- Investigators / Staff / Volunteers / Hospital /Clinical Laboratory / Analytical Laboratory Fee Payments
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- Obtaining the Financial Disclosure Agreements
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- Trial Master File (Site) set-up
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- Investigator meeting – organisation
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3. Responsibility for Study Conduct
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- Conduction of the study according to the Study protocol and the applicable legislation and regulations
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- Subjects’ recruitment, screening and randomization
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- QC of source documents throughout the study
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- QC of data entry in the eCRF
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- Managing biological samples for bioanalytical analysis
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- Ensuring adequate and timely method validation and bioanalytical results reporting
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- Direct communication with the Analytical Laboratory
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4. Responsibility for Handling Study products
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- Study products packaging labelling
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- Study products appropriate storage
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- Study products administration to study subjects
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- Final Study products reconciliation
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- Returning the Study products to the SPONSOR or destruction after SPONSOR approval
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5. Responsibility for Study Monitoring & Logistics
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- Conduction of monitoring visits
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- Assuring completeness and accuracy of all source documents/study related records
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- Safety laboratory results clinical assessment
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- Providing SPONSOR with a copy of relevant study documents on an ongoing basis
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- Providing translation services if necessary for monitoring/audits/inspections
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- Attending SPONSOR and/or SPONSOR’s authorised third parties site audits
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- Providing appropriate and timely responses to SPONSOR audits, and implementing the corresponding CAPA Plan
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- Maintaining close contact with subcontractors
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- Shipment of samples to the analytical laboratory used in PK samples’ analysis
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- Reporting of SAEs, SUSARs and SARs to SPONSOR, within the required timelines for reporting
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- Following-up SAEs, SARs and SUSARs
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- Reconciling SAEs, SUSARs and SARs with SPONSOR’s Clinical Safety person of contact
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- Assisting in reporting SUSARs to the applicable Ethics Committee
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- Notification of other relevant safety reports (e.g. pregnancy, misuse, and/or abuse) to the RA
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- Notification of other relevant safety reports (e.g. pregnancy, misuse, and/or abuse) to the EC
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- eCRF completion on an ongoing basis
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- Maintenance of backup copies of completed eCRF forms
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- Maintenance of study documentation and correspondence throughout the study
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- Data discrepancies resolution
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- Prepare and deliver to the SPONSOR the Final Clinical Study Report
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6. Responsibility for Project Management
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- Project Management and Co-ordination
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- Maintenance of continuous communication (phone, written)
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- Availability for phone conferences, when required
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- Preparation of the meeting agenda and meeting minutes
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- Conduction of internal project team meetings
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7. Responsibility for Data Management
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- Data management plan development and approval
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- Data discrepancies identification and follow-up until appropriate resolution
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- Ensuring the study database is kept updated and the data is reviewed on an ongoing basis
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- Maintaining an audit trail of the data changes in the study database
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- Coding adverse events/concomitant diseases (according to MedDRA) and medications (according to ATC)
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- Preforming SAE reconciliation
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- Performing database quality control
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8. Responsibility for Statistics and Clinical Reporting
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- Statistical/pharmacokinetic analysis plan writing and approval
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- SAS programming and validation for tables, figures and listings (TFLs)
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- Ensuring accuracy of study data reported in the TFLs
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- Protocol deviations assessment
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- Protocol deviations reporting to SPONSOR
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- Protocol deviations classified as Serious Breaches reporting to the Competent Authorities
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- Conduction of final data analysis
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- Draft Clinical Study Report (CSR) writing according to ICH E3
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- 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
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