Frequently asked questions.
If you cannot find the answer, write to us or call us.
General
Research teams running investigator-initiated clinical trials, and the sponsors, sites, monitors and inspectors working on the same study.
The AI checks the protocol against the rule sets you have switched on and drafts missing sections. Every finding shows its rule and source, and you accept or reject the suggestions.
There is no GCP approval for software. Adhera is designed to ICH E6(R3), the EU CTR and Executive Order BEK 12/2022, and undergoes risk-based validation before use in real trials.
Yes, on the department's tablet or the participant's own phone. Before use with real participants, the platform must be validated and the ethics committee must have permitted the procedure (BEK 12/2022 § 8).
Yes. With Sign light, you create a study with a title, committee or EU CT number, sites and signatories, without a protocol in Adhera.
Each module is priced separately, so you only pay for what the study uses. We will put together a proposal for your study.
Platform
By default, no. Only MitID-verified people with informed consent as a delegated task can open consents, and Adhera support only has logged emergency access, with a justification.
You can take a full export in open formats: PDFs, CSV and a JSON manifest with the audit trail.
Protocol
When the stop criterion is met: by default, no open critical findings or warnings without a justification. The criterion does not replace the assessment by the ethics committee or the Danish Medicines Agency.
Yes. Import the Word file, or start from the SPIRIT 2013 template.
Trial Master File
Yes. The index follows the trial type: trials of medicinal products under the CTR, medical devices or other health research.
Yes. Drag the files in and give the document type, date and version for each file.
Each study has its own retention date: under the CTR, at least 25 years after the trial ends (Article 58). After the trial ends, the TMF can be kept read-only Coming soon.
Sign and consent
Yes, you upload the PDF as it was approved. The text is never changed: the signature page is added at the end, and the whole file is signed.
Adults with capacity (C1), withdrawal and the trial guardian's signature are included from the start. Minors, guardianship, renewed consent, adults lacking capacity and emergency trials will follow Coming soon.
Delegation and training
No, only the first time. After that, they log in and sign with a passkey or an authenticator app.
The end date becomes a new row, which the PI signs. The earlier row stays in the log.
Meeting notes
Meeting notes is planned as a separate module after the first release. To begin with, you upload transcripts and notes yourselves.
Only the masked text, and it is only sent to an EU-hosted provider under a data processing agreement. The model's response is a draft, which the meeting chair edits and approves.
Trial calendar
Yes. The trial calendar can be shared as an iCal feed, which you subscribe to in Outlook.
Study staff with affected tasks get a training requirement, which the trial calendar tracks. Open signature workflows on the old version are cancelled and sent out again on the new one.
Inspection readiness
No. The inspector can only read documents, versions and audit trails within their access and download watermarked files.
In the same way as the inspector: an invitation with sites and an end date. The monitor can read within the assigned sites and upload monitoring reports and follow-up letters.
"Ask the study" Coming soon answers from minutes, protocol versions, changes and correspondence. Oversight & GCP visits Coming soon brings together follow-up on sponsor oversight and on initiation, monitoring and close-out visits.
REDCap
No, not initially. The connection reads the number of records, study IDs and one date field, and clinical data stay in REDCap.
No. Reconciliation uses only the study ID, and no health information is included.
Yes. The TMF, Sign, the Delegation Log and the trial calendar work without the connection, which you switch on per study.
Security and compliance
Staff sign in a closed system: every user is invited, has a role and is logged. The signature is designed to EMA's guideline on computerised systems and Part 11.
The platform is designed for hosting in the EU only, preferably in Denmark. The provider and region are named in the data processing agreement.