eConsentold – DreamIT² clinical research software

eConsent

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 documentsdocumentation

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.

KeycapabilitiesofDreamIT��eConsent

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 Study and subject organization

Begin with the relevant study and subject context so that source documentation is organized around the research being conducted.

02 Visit-related activities

Associate relevant documentation with the corresponding study visits and their operational context.

03 Documentation management

Use an organized digital environment to manage and retrieve source-related information.

04 Review and follow-up

Support the team’s review of documentation and identify items that may require further attention, subject to the product’s available workflow functions.

Designedaroundtheneedsofresearchteams

For clinical research coordinators

Spend less time navigating disconnected documentation locations and keep study-related information more organized.

For principal investigators

Support access to relevant study documentation and provide a more structured environment for research-related information.

For site managers

Gain a clearer operational view of documentation workflows across studies and subjects.

For growing research organizations

Establish a more consistent approach to managing documentation as the number of studies, subjects and team members increases.

Partofaconnectedclinicalresearchecosystem

eSource is one component of a broader clinical research environment. When used alongside other relevant solutions, it can form part of workflows involving electronic consent, regulatory documentation, study management, training and financial operations.

The goal is to reduce fragmentation between essential activities and give research teams a more connected way to manage their work.

MakeSourceDocumentationMoreManageable

Discover how Dream IT² is approaching connected clinical research documentation and explore how eSource may fit into your site's operations.