Investigator brochure

An Investigator’s Brochure can be uploaded to the study record under documentation section of the study or application. Documents are only available to sites that have an approved application, and only when a confidentiality agreement has been carried out.

Draft consent form

A draft Consent Form for approved clinical trial or compassionate use applications can be uploaded to the document register in the study or sent direct to the site administrator detailed in the application.

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

Prepare and submit FDA Form 3926, FDA Form 1572 (or equivalent)

All information required to complete a FDA Form 3926 or FDA Form 1572 form is captured within the application. Once a 3926 or 1572 form has been completed it must be submitted per regulatory guidance.

Note: Anova can provide sponsors or sites with support for regulatory engagement for a clinical trial or compassionate use program. For more details contact info.us@anovaevidence.com

Collect FDA (or equivalent) approval for file and share with sponsor/site

Once regulatory authorization for activation of a clinical trial or compassionate use case has been received, it can be added to the study record within the document section and retrieved by the sponsor/manufacturer and approved site administrators.

Prepare and submit IRB application

All information required to complete a an IRB submission is captured within the application and study record. Once a submission package has been completed it must be submitted per the preferred IRB guidance.

Note: Anova has negotiated agreements in place with preferred central IRBs for regulatory engagement for a clinical trial or compassionate use program. For more details contact info.us@anovaevidence.com

Collect IRB approval for file

Once IRB approval for activation of a clinical trial or compassionate use program has been received, it can be added to the study record within the document section and retrieved by the sponsor/manufacturer and approved site administrators.

Connect with site pharmacy to inform product preparation

Sponsors can access detailed information about a site they are connected to or sites that they have an approved application for a clinical trial or compassionate use. This profile includes pharmacy contacts to enable the communication about supply and distribution of investigational product, and documentation needed to administer the investigational product to conform to protocol requirements.

Provide approved documents to all parties

Study documentation related to any application or study 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
• Clinical trial
• Investigator’s
• Protocol amendment(s).
• Subject
• Subject
• Informed consent
• Subject information
• Subject participation
• Regulatory approval
• IRB/IEV
• IRB/IEC
• Principal investigator
• Clinical trial
• Material transfer
• IP instructions for
• IP storage condition
• IP storage condition excursion documentation ;
• Randomization
• Source
• Other study
• Protocol signature
• Protocol signature amendment
• Principal investigator
• Sub-Investigator
• Form FDA
• Financial disclosure
• Contractual agreement(s).
• Other application

Request additional investigational product

Sponsors can access detailed information about a site they are connected to or sites that they have an approved application for a clinical trial or compassionate use. This profile includes pharmacy contacts to enable communication about supply and distribution of investigational product, and documentation needed to administer the investigational product to conform to protocol requirements.

Return/destroy investigational product

Sponsors can access detailed information about a site they are connected to or sites that they have an approved application for a clinical trial or compassionate use. This profile includes pharmacy contacts to enable the communication about supply and distribution of investigational products, or for the return/destruction of investigational product if it is no longer required.