An application to participate in a study can be made to any study listed within the AnovaOS registry.  Applications can be made to participate in any clinical trial, or for compassionate use of any treatment used on an active study.

Applications can be made to any listed study and will be received by the appropriate program lead that is listed in clinical trial registries or created/amended by the sponsor.

Note:  Anova can provide sponsors with template documentation to support activation and enrolment to a clinical trial or compassionate use program.  Anova has master Agreements in place with fee schedules governing the cost of delivery of research services for clinical trials at sites registered in the system.  For more details contact info.us@anovaevidence.com .

View and filter applications:

A complete list of applications made can be viewed by clicking on the ‘Case Management’ tab in the navigation panel.

Applications can be filtered using the filter menu on the left hand side of the dashboard, and enable the user to filter by:

• Application status;
• Protocol title;
• Program lead responsible for the study;
• Clinical trial status, or,
• Compassionate use status.

Review application:

Details of an application can be viewed by clicking by:

1. Navigating to the case management tab.
2. Clicking in ‘View details’ link in the actions column of the applications list next to the application you wish to review.
3. The user will then be presented with an application summary including study information, sponsor and site information, with related links to each section.

A second navigation panel will allow the user to review the details of the application made including:

• Study identification;
• Research site and eligible physician information;
• A clinical summary of the case, including:
  • Subject medical conditions;
  • Laboratory results;
• Eligibility criteria met for the study;
• Whether additional patients can be identified for the study at the applicant site;
• IRB/IEC credentials; and,
• Study coordinator, pharmacy contact and other application contact information.

Note: Anova can provide sponsors with template documentation to support activation and enrolment to a clinical trial or compassionate use program.  For more details contact info.us@anovaevidence.com

Approve or decline study application:

A sponsor/manufacturer can approve or decline an application received. Sponsors will be notified of any applications received (provided notifications are not disabled) and can access the application directly through the notification, or via the Case Management tab.

1. On receipt of an application, the user will be presented with options to either approve, decline or request further information should clinical info provided be insufficient to reach decision.
2. On selection of an option, the sponsor will have the option to provide comment regarding decision for the research site’s information.
3. If the application is approved, the site and its study personnel will have access to the sponsors profile to allow seamless communication in activating and enrolling a patient.
4. An approved application will automatically generate a patient profile using deidentified information in the patient’s module. This profile may be used to manage patient information and status, allowing for seamless communication between site and sponsor for the activation and enrolment of the patient.

Request application clarifications:

If an application lacks sufficient details, sponsors can request more information by:

1. Opening the application in the Case Management tab.
2. Selecting ‘Request additional information’ in the bottom-left corner.
3. Entering specific clarification requests.

The research site administrator will receive both an email and in-system notification, prompting them to respond and re-submit the application.

Application history:

A detailed case history is retained for every application, which can be accessed in the left hand menu of the application detail dashboard.  This includes a time and date stamp for all actions taken on the application.

View application documentation:

Study documentation related to any application can also be viewed by navigating to “View study documents” in the left hand panel of the application detail dashboard.

Note: Study documentation is only available to access for organizations that have completed and uploaded a confidentiality agreement to the study document library. 

The study document library consists of all core elements of the TMF Reference Model, including but not limited to:

• Confidentiality agreement;
• Clinical trial protocol;
• Investigator’s brochure;
• Protocol amendment(s);
• Subject diary;
• Subject questionnaire;
• Informed consent form;
• Subject information sheet;
• Subject participation card;
• Regulatory approval notification;
• IRB/IEV approval;
• IRB/IEC composition;
• Principal investigator CV;
• Clinical trial agreement;
• Material transfer agreement;
• IP instructions for handling;
• IP storage condition documentation;
• IP storage condition excursion documentation;
• Randomization plan;
• Source documents;
• Other study documents;
• Protocol signature page;
• Protocol signature amendment page;
• Principal investigator CV;
• Sub-Investigator CV;
• Form FDA 1572;
• Financial disclosure form;
• Contractual agreement(s);
• Other application documentation.

A sponsor can upload documentation to the study record by navigating to the document section of the study and choosing to upload a document to the corresponding document field.