Medrio eClinical Form


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IMPORTANT NOTE:
After study is available, please add a second study administrator to all environments (i.e. DEV, TEST, LIVE) immediately.

Study Administrator




Second Study Administrator




Medrio Study Title







Only use this option if you have a specific or customized Server instance within Medrio.
NOTE: Studies located on our servers in China are not compliant with GDPR. Please initial below to acknowledge and confirm your selection.

Applies only to the timing of certain maintenance windows, where possible, so that they coincide with overnight hours in the APAC region.  Data is currently stored in the US.

Curious about SSO? Contact Support to learn more.

Once a study has been provisioned on multiple domains, you cannot later remove this study from one of the domain instances. Please be sure you have read the Medrio EDC User Guide page regarding SSO Domains as well as the Release Notes for Medrio Version R42.1 released 24-Feb-2024 for additional information regarding multi-domain SSO studies. 


Please enter your Medrio SSO Domain name.

Please enter your Medrio SSO Domain. If you have more than 1 Domain, please select "Add Another Response" for additional SSO Domain names
Branding


(Only letters, numbers, and dashes)

(Only letters, numbers, and dashes)

(Only letters, numbers, and dashes)
Study Configuration Details


Hard data deletion will be enabled on dev and test studies. Note: Hard data deletion cannot be enabled on a LIVE study instance.

*Please Note: Enabling this feature will disable certain analyses and reports in Medrio

Note: Repeating Forms and Visits allows by default up to 99 instances. By selecting "Yes" for this option, the maximum number of instances becomes 999


Please consult your Medrio Order Form before requesting any additional modules.

MyMedrio Participant Portal


(https://XXX.nax.filloutyourform.com)


If enabling ePRO Remote, the URL should be the same as ePRO Remote URL.

(https://XXX.nax.filloutyourform.com)

Only Letters, Numbers, and Dashes

Only Letters, Numbers, and Dashes

Only Letters, Numbers, and Dashes


Note: This feature cannot be enabled for studies that already have subjects added, as the Subject Self Registration can only be used with Medrio ID numbers, not Subject IDs.
Additional Features

As of the release of Medrio Version R42.1 on 24-Feb-2024, Advanced BYO reporting is automatically included in all newly provisioned Medrio studies.



(Note: New versions of MedDRA and WHO Drug are released annually in March and September. It may take up to 2 weeks after the new version is released for it to be available in Medrio for selection. New versions of the dictionary will be added to this list once it becomes available)




Customer Number













(Note: Medrio does not provide a license to use coding dictionaries. Please provide contact information for your license holder below so we may complete verification.










Before proceeding with the addition of the FLAT feature, please review our User Guide page describing the functionality of FLAT by clicking here. 


Once this option has been enabled on the study, it cannot be disabled.






Advanced BYO reporting is now included in EDC

Targeted Monitoring is now included in EDC


The following changes will be made to all instances of this study to allow data to be exchanged between the EDC and RTSM databases:

  •  ODM and Rest API enabled. This will be added to DEV, TEST and LIVE instances and will allow communication between the EDC and the RTSM databases.
  • Events API enabled that will alert the RTSM database when EDC forms are saved
  • The RTSM database will be whitelisted to secure the communications between the EDC and the RTSM databases
  • API logging will be set to “On Errors Only” and any API error emails will be sent to the Medrio RTSM support team

API Keys will be sent to you. There will be no need for you to send the keys to the RTSM PM or development team. 


As of the release of Medrio Version R42.1 on 24-Feb-2024, when RTSM is enabled on a study, the API configuration, roles, and users who are required for the RTSM integration will now automatically be added to that study when RTSM is enabled. This functionality is automatically applied to studies enabling RTSM. 

By checking the box below, you are permitting Medrio to make these changes on your behalf.



Please only select this if you have already completed your CTMS kickoff meeting with Medrio.




Need help on this section? Check out this article.

For Import/Export & DataViews API

Note: if your study will use OpenAPI or DataViews you must have API enabled in the DEV instance in order to access the required permissions


NOTE: After Support sends you your API keys, we are NOT able to resend them. They will have to be reset if you lose them.

NOTE: When API is initally setup for a study the Support Team is required to generate new keys. This will not affect any customer-level keys.


IP Addresses

This is used for Whitelisting IP Addresses for added security and is OPTIONAL.


For multiple addresses, please separate by a comma with no spaces

For multiple addresses, please separate by a comma with no spaces

For multiple addresses, please separate by a comma with no spaces

These are the email addresses that will receive notifications on success and/or errors.


For Events API


A Listener URL is a server that you configure at a specific web address (URL) to listen for incoming HTTP `POST `messages that are triggered when an event occurs. Listener URL's are required to enable Events/Subscription Events API. If you do not have a valid Listener URL, Events API cannot be enabled.





Note: Medrio will generate API Keys, and provide them in a separate email via an encrypted link

For Subscription Events API

Please submit one request per subscription. If multiple subscriptions are needed, please submit an additional request for each subscription 



A Listener URL is a server that you configure at a specific web address (URL) to listen for incoming HTTP `POST `messages that are triggered when an event occurs. Listener URL's are required to enable Events/Subscription Events API. If you do not have a valid Listener URL, Subscription Events API cannot be enabled.













Customer-Level/Enterprise-Level API Configuration

Please note that customer-level API grants access to all data in all studies provisioned under your organization's name in our system


NOTE: After Support sends you your API keys, we are NOT able to resend them. They will have to be reset if you lose them.
IP Addresses

This is used for Whitelisting IP Addresses for added security and is OPTIONAL.


For multiple addresses, please separate by a comma with no spaces



NOTE: Enterprise API users can also be added by Cross Study Portal Administrators. Enterprise users can access all the study data associated with their accounts via OpenAPI or DataViews.



NOTE: Enterprise API accounts should not be used to access Medrio EDC. Medrio Support will create a new enterprise user account for the email listed above.

Note: Medrio will generate API Keys, and provide them in a separate email via an encrypted link.

For customer-level API, we need someone to verify your authorization to make this request. We will reach out to the person you list below to confirm authorization. Please list someone other than yourself who can verify this request.





Cross Study Portal Request



Please separate study titles with commas and make sure the study title matches what is shown in EDC.





When adding Cross Study Portal Administrators we need someone to verify your authorization to make this request. We will reach out to the person you list below to confirm authorization. Please list someone other than yourself who can verify this request.










Engility CTMS Request





Who at your organization will be reaching out to
Pharmaseal with questions or issues?




After submitting this form, all CTMS users will be
granted SSO with Medrio/Engility






When adding Engility CTMS Users we need someone to verify your authorization to make this request. We will reach out to the person you list below to confirm authorization. Please list someone other than yourself who can verify this request.







Study Details


ID number found on https://clinicaltrials.gov






Describe the disease or condition that will be the focus of the study.










Product and Compliance Updates

Technical Support for your Production Study

Note: Medrio will NOT make any changes to the production study without your express written consent.


Archive Study

Only a Study Administrator can request the archiving or un-archiving of a study. If your role within the study is not that of a study administrator, your request will not be processed. 


Please note that unarchiving a study comes at an additional cost. Before submitting this form, ensure all study close-out activities are complete before archiving. Click here for study close-out best practices.


NOTE: Medrio will archive this study upon receipt of this form

eSignature Configuration Change


Dictionary Configuration Change

CHANGES COMING TO DICTIONARY CODING UPVERSIONING

Coming with the release of Medrio version R42.4 scheduled for release on September 21, 2024 there will be changes in how the Medrio EDC handles changing your dictionary coding version mid-study. For more information on how this change will affect the upversioning of your study please review our Release Article within Medrio Community. 

(Note: New versions of MedDRA and WHO Drug are released annually in March and September. It may take up to 2 weeks after the new version is released for it to be available in Medrio for selection. New versions of the dictionary will be added to this list once it becomes available)



(Customer Number)




(Customer Number)










(Note: Medrio does not provide a license to use coding dictionaries. Please provide contact information for your license holder below so we may complete verification.)








If you have already completed Dictionary Coding on your study and need assistance updating to a newer version of the dictionary, please review our Knowledge Article about How To Change Dictionary Versions Mid-Study

Database Lock / Unlock


Database Pause / Un-pause


Mid-Study Change Request (Other)


If your study is already on an SSO Domain and want to add this study to the Medrio Domain, please enter "Medrio" as the SSO Domain name above. Otherwise, please enter your existing SSO Domain name above. If you do not currently have an SSO Domain created, please contact your account manager for further assistance.
Please review our User Guide page describing the functionality of FLAT by clicking here.

(Note: It is not recommended to add FLAT if you already have participants enrolled in the LIVE study. Once FLAT has been enabled on the study, it cannot be disabled)






(Only letters, numbers, and dashes)

(Only letters, numbers, and dashes)

(Only letters, numbers, and dashes)









Note: This feature cannot be enabled for studies that already have subjects added, as the Subject Self Registration can only be used with Medrio ID numbers, not Subject IDs.

Only Letters, Numbers, and Dashes

Only Letters, Numbers, and Dashes

Only Letters, Numbers, and Dashes

NOTE: Hard Data deletion will be enabled in DEV in TEST when Targeted Monitoring is enabled


*Please Note: Enabling this feature will disable certain analyses and reports in Medrio

The following changes will be made to all instances of this study to allow data to be exchanged between the EDC and RTSM databases:

  •  ODM and Rest API enabled. This will be added to DEV, TEST and LIVE instances and will allow communication between the EDC and the RTSM databases.
  • Events API enabled that will alert the RTSM database when EDC forms are saved
  • The RTSM database will be whitelisted to secure the communications between the EDC and the RTSM databases
  • API logging will be set to “On Errors Only” and any API error emails will be sent to the Medrio RTSM support team

API Keys will be sent to you and the RTSM development team. There will be no need for you to send the keys to the RTSM PM or development team. 

Next step: In each instance, an “API” user and role must be created to allow the EDC and the RTSM databases to exchange data. You must create the API role with the following permissions: Enroll Subjects, Edit Subject Information, Form Data (All-Write), Upload Data(All-Forms). Create the api user with username and email of “apiuser@medrio.com” and assign to the API user role with access to all sites.

By signing below, you are permitting Medrio to make these changes on your behalf.

Enable New Release Features

Only available for studies with ePRO Remote enabled at this time

Only available for studies with ePRO enabled at this time

NOTE: Hard Data deletion will be enabled in DEV in TEST when Targeted Monitoring is enabled



If you need to add multiple features, please list them, separated by commas.

RTSM Decommissioning Request 


I hereby request that the RTSM for the above project is decommissioned, removed
from the server and archived.
Please contact Medrio support if you require a copy of the final database export.
RTSM Database Lock Request


I hereby request that the database for the above project is locked, and that the 
accounts for all site users are inactivated immediately. Below signature confirms 
approval for the request.
Study Administrator Change Request

This form should only be submitted to Medrio Support if you need to add a new administrator to a study and there is no existing study administrator to accomplish this task. The Administrator Change Request can only be approved and submitted by a member of your organization with the necessary authorization (typically a Senior Manager, Director, or VP). Upon receipt, Medrio Support will validate the authorization of the requestor and, if confirmed, the new study administrator will be added to the requested study/studies.

 

Please note that the person requesting the addition of the administrator cannot also be the person being added as an administrator to the study. This is a security measure in place to ensure only necessary parties are added to the study as administrators.


Additionally, if the user requesting to be added to the study as the new administrator is already a member of the study's user list but in a different capacity (I.E. Data Manager, Sponsor User, Data Entry, etc...) Medrio Support is unable to alter the existing role assignment. We are only able to add a username to the study that is not currently a member of that study's user list.  


Requestor/Approver Section

I, the undersigned Approver, am requesting that Medrio assign the Study Administrator role the New Administrator provided in the next section. The previous Study Administrator is no longer able to perform this function as they are no longer working on the below-referenced study/studies. 








New Administrator Section

Please add the below person as a Study Administrator.





For any issues, questions, or comments, please call Medrio support at (877) 763-3746 or submit a ticket to the Medrio Support team.

Contact Information