DOCUMENT TRANSLATION FORM

I. Document Translation/Backtranslation/Review Request

Study code: APD334-202
Project Manager/Division Head: Isabela Fernandez
Requested by: Teresa Accettura
Document title: Holter Subject Guide Commented [Comment1]: For multiple documents
please include a numbered list referencing the
Translation Backtranslation Review documents by their titles. IMPORTANT: The wording
used for document titles must be compliant with
Type of document: TMF standard titles, where applicable.

Study protocol/protocol amendment/synopsis

Patient information and/or informed consent form
Data collection tools (CRFs, diaries, questionnaires, etc.)
Instruction manuals
Sponsor’s communication
Newsletters
Drug info (labels, investigator’s brochures, administration instructions, etc.)
Presentations
CIOMS/MedWatch/SAE reports
Regulatory documents (applications, approvals, notifications, reports, etc.)
Financial/legal/administrative documents (contracts, powers of attorney, etc.)
Commented [Comment2]: Please choose from the
Source documents (discharge summaries, medical charts, etc.) drop-down menu or use the field to type in the
Other (please specify) language name. IMPORTANT: when requesting
translations from regional language varieties,
please choose the relevant menu item or use the
Source Language: English field to specify.
Target Language: Romanian Commented [Comment3]: Please choose from the
drop-down menu or use the field to type in the
Priority Level: Critical High Medium Low language name. IMPORTANT: when requesting
translations into regional language varieties,
Date of request: 29-DEC- 2019 please choose the relevant menu item or use the
field to specify.
Desired delivery date: 03-DEC- 2019
Commented [Comment4]: Critical: Deadline non-
Desired delivery time (for critical and high-priority jobs only): CET negotiable, start work immediately; divert resources as
necessary; extra charges and acceleration techniques
II. Document Translation/Backtranslation/Review Tracking (to be are authorized
High: Not a critical emergency but to take precedence
completed at TD) over routine tasks; to be delivered upon completion of
any jobs on a critical path but within the approved
deadline
Translator: Medium: Routine tasks with negotiable deadlines
Low: Work that is not tied to any specific mission
Peer reviewer, if applicable: milestone; moveable deadline

Reviewer(s): Commented [Comment5]: DD-MMM-YYYY

Commented [Comment6]: DD-MMM-YYYY
Delivery date: dd-MMM- yyyy
Commented [Comment7]: DD-MMM-YYYY
QSD code: SDF-TD-XF-001-05
Effective date: 03-DEC-2019