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A management plan will be formulated and will be documented in the clinical notes.
These administrative changes will be agreed upon by the steering committee, and will be documented in meeting records.
These administrative changes will be agreed upon by BCIRG and Aventis, and will be documented in a memorandum.
Patients and physiotherapists will be informed that any adverse events should be reported to and will be documented by the research team.
Treatment failure will be defined as no improvement 14 days after presentation and/or 5 days after completion of treatment, and will be documented.
Minor administrative changes to the protocol will be agreed on by the project management committee and will be documented in a memorandum.
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As of the last year, Aparna and Kopa have joined Video Volunteers as Community Correspondents and will be documenting the daily travails of their people.
This assessment and education plan and the intervention and outcomes will be documented in the education record.
The presence of advance directives, advance care plans and specific requests regarding hospitalisation and resuscitation will be documented at baseline and during the course of the intervention.
The assessment and education plan, intervention, and outcomes will be documented in the education/health record.
All AEs and SAEs will be documented on CRF in detail, and will be reported to the Quality Monitoring Board (QMB) and Biological and Medical Ethics Committee BMECC).
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