eConsent – DreamIT² clinical research software

eConsent — Electronic Informed Consent

eConsent:BringingGreaterClaritytoClinicalTrialConsent

Support organized informed consent workflows with a digital approach to consent documentation, participant records and study-related activities.

AMoreOrganizedApproachtoInformedConsent

Informed consent is a fundamental part of ethical clinical research. Before participating in a clinical trial, individuals need to receive relevant information about the study and make an informed decision about participation.

For research sites, managing consent documentation involves more than collecting a signed form. Teams must organize consent records, maintain visibility into consent status and manage documentation as studies and protocols change.

Traditional paper-based processes can create additional administrative work. Documents may be stored in different locations, consent statuses may need to be updated manually, and teams may find it difficult to maintain a clear overview of consent-related activities.

Dream IT² eConsent is intended to support a more organized digital approach to informed consent management, connecting consent-related information with broader clinical research workflows.

Whyclinicalresearchteamsneedorganizedconsentworkflows

Managing multiple consent documents

Clinical studies may involve different consent forms, revisions and supporting documents. Keeping them organized and associated with the correct study is an important operational responsibility.

Maintaining participant records

Research teams need to know which consent documentation is associated with each participant and be able to locate the relevant records when required.

Handling consent updates

Protocol changes and updated consent documents can introduce additional coordination requirements, including identifying participants who may need to be re-consented.

Monitoring consent activities

Coordinators need an organized way to review consent-related activities and identify outstanding documentation.

KeycapabilitiesofDreamITeConsent

1. Digital consent documentation

Organize consent documents and related information in a digital environment. A structured approach helps research teams manage consent records alongside other study documentation rather than treating them as isolated files.

2. Participant consent records

Associate consent-related information with relevant study and participant records. This provides a useful organizational foundation for reviewing consent documentation throughout a participant's involvement in a study.

3. Consent status visibility

Maintain a clear view of consent-related statuses. Status-based organization can help research teams distinguish between records requiring attention and those that have progressed through the applicable workflow.

4. Re-consent management support

Changes to study documentation can require additional consent activities. An organized approach to re-consent information can help teams identify relevant records and coordinate follow-up activities.

5. Connected study workflows

Consent activities are closely related to subject management, study documentation and regulatory records. A connected environment can help teams manage these activities in the context of the wider study.

HoweConsentfitsintotheparticipantjourney

01 Consent preparation

Organize the consent documentation associated with the applicable study and consent process.

02 Participant consent

Manage consent-related records in the context of the participant’s study involvement. The exact signing and presentation options depend on the implemented product.

03 Consent record management

Maintain organized consent information associated with the participant and study.

04 Review and follow-up

Review consent status and manage follow-up activities when changes or re-consent requirements arise.

Supportingresearchteamsthroughouttheconsentprocess

For research coordinators

Organize consent records and maintain visibility into participant-related consent activities.

For investigators

Support the management and review of consent-related study documentation.

For site managers

Maintain a more structured overview of consent workflows across active studies.

For Participants

A well-designed consent process can help make study information easier to understand and consent-related interactions more organized.

Any participant-facing digital features depend on the specific product implementation.

Connectedconsentandclinicaloperations

Consent is closely connected to several other research activities. It relates to participant records, study documentation, regulatory files and ongoing visit workflows. Connecting these areas can help reduce the administrative separation between consent and everyday site operations.

BringGreaterOrganizationtoConsentManagement

Discover how Dream IT² approaches electronic informed consent and connected clinical research workflows.

Request a Demo