Easy
Press forgot pin
BYOD
Bring Your Own Device
The event of the first patient being enrolled in a clinical study.
FPI / first patient in
Give 3 common PII that Helpdesk will acquire on a customer call
name, phone number, email address
Screen and enroll subjects
CRC
If the patient was not able to remember their password, what do we do?
Help in password reset / press forgot password and enter correct email
Single sign-on portal (one login ID and one password) that authenticates your identity and authorizes access to your home page and from there to all your Medidata applications and eLearning courses
iMedidata
An individual selected by the sponsor or CRO to oversee the initiation, progress, and conduct of a clinical trial.
CRA
2 Modes in PC app
Personal and Multi user mode
Attend all visits and undergo all procedures as scheduled
Patient/Subject
latest version of PC app for IOS and Android
2020.4.0
a.k.a Clinical Trial or Trial
Study
Medidata provisioned devices used: Device used IOS tablet/iPad
Site mode and ClinRO
•If you attempted to log in with an incorrect password, you will be locked out for 1 minute after?
5 failed attempts
Coordinate all aspects of a clinical project, from finance to clinical to regulatory
PM
What if the patient cannot access their valid email address for some reason and they were not able to reset their email account, what will the Helpdesk do?
Provide the password reset link to the CRC
Organizes sites and studies for management and organization purposes
Study Group / Sponsor / Group of Study
Procedure in which one or more parties in a trial are kept unaware of which treatment participants have been assigned to or was received
Blinding
Patients will be able to complete their forms while offline but the data will be transferred to Rave once the device has internet connection. What is this type of access?
Offline mode
üReview data in Rave & query sites to clarify/correct problem data
DM/Data manager
What will Helpdesk do if the subject used a dummy email address and the study has not signed NTF?
send an email to Customer Advocacy (cs-advocacy@mdsol.com),
Process of assigning trial subjects to treatment or control groups using an element of chance to reduce bias
Randomization
Patient Cloud allows a faster login method. What is this method?
PIN code usage
Workflow: patient visits the site, Site personnel logs in the app and hand over the site device to the patient. Patient will complete the required forms and give it handover back to Site
Site mode/Clinro
Provides support to the pharmaceutical, biotechnology and medical device industries in the form of research services outsourced on a contract basis
Contract Research Organization (CRO)