Overview
Nowadays the majority of Clinical Trials are multi-national involving various countries, so the main (“master”, typically English) versions of Study Materials should be adapted as per country-specific requirements in order for Sponsor to obtain trial authorisation from Regulatory Authorities and Ethics Committees.
Study Materials are covered in our article Study Materials Development and Review Service
Aim
This article aims to briefly introduce the process of Study Materials’ adaptation to satisfy country-specific requirements.
Process
In most of cases the following Study documentation requires country-specific adaptation:
- Informed Consent Forms for subjects to document their agreement to participate in a given Clinical Trial
- Subject Emergency Cards (if used) containing essential Clinical Trial information (Sponsor name, protocol title, general information on the Investigational Medicinal Product etc.) along with contact details of Investigator and Sponsor in case of emergency situations
- Scales and Questionnaires (if used) aiming at collection of information necessary to analyse various aspects of subjects’ participation in a given Clinical Trial
- Subjects’ Recruitment materials, if used (including advertisements)
- Investigational Medicinal Product Labels which will be affixed to the Study Drug in a given Clinical Trial
- Clinical Trial Insurance documentation for participating subjects
- Study Plans (e.g., Project Management Plan, Study Start-up Plan, Clinical Monitoring Plan, Recruitment Plan etc.).
All Study documentation being provided to subjects should always be in language understandable to clinical trial participants , therefore it should be appropriately translated to all official languages in the particular country and included into the submission dossier for Regulatory Authorities and Ethics Committees review before they can grant Clinical Trial Authorisation.
Investigational Medicinal Product Labels are always submitted for Regulatory Authority’s review and used in official language of the country in which a given Clinical Trial is planned to be conducted.
Other documentation mentioned in the above list can be used in English or be bi-lingual (English + official language of the country in which Clinical Trial is to be conducted).
Below is a non-exhaustive list of applicable actions which are performed in order to ensure that Study documentation is compliant with country-specific requirements:
- Check that documentation is in line with country-specific legislation and regulations governing the conduct of Clinical Trials (both with respect to content and document availability)
- Check that documentation is accurately identifying the study Sponsor (e.g., name and address, contact details etc.)
- Check that the Study title is in accordance with the Clinical Study Protocol, and its identification number
- Check if Investigator’s and Institution’s name and address are accurately specified or there are allocated fields to enter this information (e.g., during Informed Consent Process)
- Check that Regulatory Authority, Ethics Committee names and approval status are accurately specified
- Check that Clinical Trial Insurance information (e.g., company name, insurance agreement/policy number, contact details or responsible person) is accurately specified
- Check that emergency contact details of Clinical Trial Site are specified
- Check that documentation (e.g., Informed Consent Form) has appropriate signature fields for subject, his/her legally authorised representative (if applicable), impartial witness (if applicable); and for responsible Investigator obtaining Informed Consent Form
- Check that all document’s headers and footers contain accurate Clinical Trial specific information, type of the document itself, as well as appropriate versioning, dating and pagination
- Check that country-specific requirements for Data Privacy protection are clearly specified in applicable documentation
- Check that country-specific requirements for handling of biological samples (e.g., blood, urine, tissue samples etc.), including their exportation abroad with further analysing in Central Laboratory are clearly specified in applicable documentation
- Check that country-specific requirements for managing subject’s complaints and appeals with regards to Clinical Trial participation are clearly specified in applicable documentation
- Check that Investigational Medicinal Product Labels clearly specify manufacturer, Clinical Trial specific information, pharmaceutical dosage form, route of administration, quantity of dosage units, strength/potency, batch and/or code number to identify the contents and packaging operation, directions for use, specification “For clinical trial use only” etc.
During the adaptation process the clear and proactive communication between Contract Research Organisation and Sponsor ensures that the process is executed smoothly and reduces the amount of potential deficiency letters received from Regulatory Authorities and Ethics Committees.
Only approved by Sponsor English country-specific versions of Study documentation are sent for corresponding translation for subsequent use in a given Clinical Trial.
Carpathian Research Group capabilities
CRG as a CRO has a proven track record of country-specific adaptations of Study documentation leading to Clinical Trial authorisations and having no documentation-related findings during audits & inspections.
Information on all other Clinical Trial services that we provide could be found at www.crg.global
You can contact us at info@crg.global