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Table 2 User roles by access levels to the Cochlear P-IROS and functionality

From: A global patient outcomes registry: Cochlear paediatric implanted recipient observational study (Cochlear™ P-IROS)

 

Investigator

Sponsor

Service provider

User (role)

Chief investigator*

Unlimited investigator*

Limited investigator*

Study nurse

Cochlear global project leader

Cochlear country project leader

Database administrator

Accepts terms of registry agreement

√

-

-

-

-

-

-

Obtain patient consent

√

√

√

-

-

-

-

Enter patient data

√

√

√

√

-

-

-

Edit patient data

√

√

√

√

-

-

-

View and download patient data

√1

√1

√2

-

√ 3

√4

√5

Transfer patient

√

-

-

-

-

-

-

Notified of new clinics and patients

-

-

-

-

√

√

√

Number of users permitted per study site

1¥

≥1

≥1

≥1

NA

NA

NA

  1. NA: Not applicable.
  2. Notes:
  3. √ indicates required functionality.
  4. - indicates prohibited functionality.
  5. * The term clinician used throughout the manuscript refers to the responsibilities of the: Chief Investigator, Unlimited Investigator and Limited Investigator. The Study Nurse user profile will be applicable for data entry purposes only and is, therefore, not typically a clinician.
  6. ¥ Each site requires one Chief Investigator, as a maximum. There is no upper limit to the number other investigators or study nurses that may be involved.
  7. 1. Can view/download data of all site’s patients.
  8. 2. Can view/download data of the investigator’s patients only.
  9. 3. Can view/download data of patients at the global level.
  10. 4. Can view/download data of patients at the national level.
  11. 5. Can only view patient data on request, for troubleshooting purposes, but cannot download patient data.
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BMC Ear, Nose and Throat Disorders

ISSN: 1472-6815

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