eRegulatory – DreamIT² clinical research software

eRegulatory / eISF — Electronic Investigator Site File

eRegulatory/eISF:AStructuredHomeforClinicalTrialDocumentation

Organize essential regulatory documents, manage document statuses and maintain a more consistent view of clinical research site files.

BringYourEssentialRegulatoryDocumentsTogether

Regulatory documentation is an essential part of clinical trial site operations. Investigator site files contain important records associated with the conduct and oversight of clinical research, including approvals, study documents, investigator information and training records.

As studies progress, the volume of documentation can grow considerably. Managing files through paper binders, shared folders and separate applications can make it difficult to maintain consistent organization and locate the correct documents

Dream IT² eRegulatory/eISF is designed to provide an organized electronic environment for clinical research site documentation. It supports a structured approach to document organization and status visibility, helping teams manage regulatory records as part of their wider study operations.

Thechallengesofregulatorydocumentmanagement

Complex document organization

Regulatory files can include numerous document types, versions and study-specific records. Without a consistent filing structure, locating the right information may require considerable effort..

Document status management

Research teams need to understand which documents are pending review, approved or require additional attention. Tracking these activities manually can make oversight more difficult.

Version complexity

Updated protocols, forms and other study documents can result in multiple versions. Maintaining clarity about which version is relevant is an important part of document management..

Coordination across site personnel

Investigators, coordinators and other authorized personnel may all have responsibilities related to regulatory documentation. They need an organized way to work with relevant records.

KeycapabilitiesofDreamITeRegulatory/eISF

1. Structured electronic site files

Organize regulatory documents within a structured electronic site file. A consistent folder and category structure helps research teams manage documents according to their study and operational context. Instead of navigating multiple disconnected locations, users can work within an organized document environment.

2. Document classification and organization

Clinical research documentation covers many different categories. Organizing records by document type and study association makes them easier to browse and manage. A structured library can support more consistent filing practices across research studies and site activities.

3. Document status tracking

Maintain visibility into document statuses, including records that are awaiting approval or have been approved. Status-based organization helps teams identify documents that may require review or follow-up. This can provide a clearer operational picture of the current state of the site's documentation

4. Document version visibility

Documents may change throughout the lifecycle of a clinical study. Maintaining visibility into document versions and their associated information can help teams understand the history and current state of their files. Version-related capabilities should be used according to the product's actual revision and approval workflow.

5. Upload and document management

Manage document uploads within the context of relevant studies and document categories. Organized upload information can help teams navigate their records and review documentation as part of their daily work.

6. Study-level document visibility

Associate regulatory records with their relevant studies and site activities. This can help users review documentation in the context of the research being conducted.

HoweRegulatory/eISFsupportsthedocumentlifecycle

01 Create a structured document library

Organize the site’s electronic files using relevant study and document categories

02 Upload and classify documents

Add relevant records and associate them with the appropriate document types and study context.

03 Review document information

Use document status and available version details to understand the current state of records.

04 Manage follow-up activities

Identify documents requiring attention and coordinate the next steps according to the site’s established procedures.

05 Maintain an organized site file

Keep relevant documentation within a consistent electronic filing structure as the study progresses.

Supportingthepeopleresponsibleforsitedocumentation

For clinical research coordinators

Organize study files, locate relevant documents and manage routine document-related activities.

For investigators

Maintain a more structured view of essential study documentation and associated records.

For regulatory coordinators

Work with a centralized electronic filing structure and review the status of relevant documents.

For site managers

Improve visibility into the organization and status of site documentation across studies.

Aconnectedapproachtoresearchdocumentation

Regulatory documentation is closely associated with training, consent, source documentation and study management. A connected clinical research environment can help teams manage these related activities without treating every document workflow as a separate process.

CreateaMoreOrganizedRegulatoryWorkflow

Explore how Dream IT² eRegulatory/eISF can support the way your research site manages essential study documents.

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