REDCap for CTIMPs: Database Development and IMP Management
Can REDCap be used for CTIMPs?
REDCap can provide a strong foundation for CTIMP data collection, but REDCap on its own does not automatically provide all of the infrastructure required to run a compliant CTIMP.
A standard REDCap project may be suitable for collecting clinical trial data, managing electronic case report forms, participant visits, surveys and study records. However, CTIMPs often require additional controlled processes for areas such as:
IMP allocation
Strict version control and validation
Maintenance of blinding
Pharmacy dispensing workflows
IMP stock and inventory management
Batch and expiry tracking
Drug accountability
Returns and destruction
Emergency unblinding
Role-restricted access to treatment information
The suitability of a particular REDCap environment for CTIMP data collection also depends on factors including:
The organisation's hosting environment
Local governance arrangements
Validation requirements
Version control
User access and permissions
Study-specific testing
Audit trails
Change management
Backup and recovery procedures
Data management plans
Applicable regulatory requirements
Simply creating a database in REDCap does not, by itself, create a complete CTIMP data-management and IMP-management system.
AGC DATA can support the design of the clinical trial database and wider CTIMP data architecture, while CRISPNet provides an additional specialist layer for IMP-management processes that may sit outside the core clinical trial database.
Together, this provides research teams with a practical way to combine an established EDC environment with the additional workflows required for complex CTIMP delivery.Using REDCap for a CTIMP?
AGC DATA designs clinical trial databases and IMP-management workflows around your study protocol, giving research teams a practical route to robust CTIMP data infrastructure without the cost of commissioning a fully bespoke all-in-one clinical trial platform.
For organisations with their own REDCap environment, AGC DATA can design the database externally and provide an import-ready REDCap data dictionary and supporting project specification. Your institution can then review, import, host and manage the database within its own approved REDCap environment.
For commercial studies requiring a hosted commercial solution, another appropriate EDC environment can be considered.
CRISPNet can then provide an additional specialist IMP-management layer, designed to work alongside REDCap or other suitable clinical trial data systems.
From protocol to an import-ready REDCap database
AGC DATA translates your clinical trial protocol into a structured database design tailored to the requirements of your study.
This can include:
Electronic case report forms
Participant and visit schedules
Longitudinal study workflows
Randomisation requirements
Blinded and unblinded data structures
Data-validation rules
User roles and permissions
Data-quality reporting
Participant-facing surveys
Sample tracking
Pharmacy and IMP workflows
Reporting and export requirements
Where an organisation operates its own REDCap environment, the completed database structure can be supplied as an import-ready REDCap data dictionary for the institution to review, import and manage within its locally governed system.
This allows research teams to benefit from specialist database design while retaining control of their own REDCap environment, hosting arrangements and institutional governance.
What REDCap can support
Depending on the locally available functionality and configuration, REDCap can support:
Electronic case report forms
Participant and visit management
Study questionnaires and surveys
Data validation
Role-based permissions
Randomisation
Automated notifications
Data-quality reporting
Audit trails
Data exports and reporting
For many CTIMPs, however, collecting the clinical data is only one part of the required infrastructure.
A study may also need to manage:
Treatment allocation
IMP pack allocation
Pharmacy dispensing
Inventory monitoring
Batch tracking
Expiry monitoring
Drug accountability
Returns and destruction
Maintenance of blinding
Emergency unblinding
This is where CRISPNet provides an additional specialist layer.
CRISPNet
Clinical Research IMP Supply & Processing Network
CRISPNet — the Clinical Research IMP Supply & Processing Network — is a flexible IMP-management framework developed by AGC DATA for Clinical Trials of Investigational Medicinal Products.
It is designed to connect clinical trial data with the operational processes required to manage IMP supply, allocation, pharmacy workflows, accountability and emergency unblinding.
It can be configured to work alongside REDCap and other suitable clinical trial data environments, allowing research teams to retain control of their chosen EDC platform while adding specialist IMP-management functionality where it is required.
The exact technical approach is agreed with each organisation according to its existing systems, infrastructure, governance arrangements and study requirements.
What CRISPNet can support
Depending on the requirements of the study protocol, CRISPNet can support:
Randomisation and treatment allocation
Maintenance of study blinding
IMP pack allocation
Pharmacy dispensing workflows
Inventory and stock monitoring
Batch tracking
Expiry-date monitoring
Drug accountability
Returns and destruction records
Automated study notifications
Low-stock alerts
Emergency unblinding
Role-based access
Traceable audit records
Each implementation is configured around the individual study protocol, participating sites, pharmacy processes and sponsor requirements.
REDCap randomisation versus IMP management
Randomising a participant to a treatment group is only one part of the process.
A complete IMP workflow may also need to determine:
Which treatment group has been assigned
Which IMP pack is eligible for allocation
Whether an appropriate pack is available at the correct site
Whether the pack remains within its permitted expiry period
What information pharmacy requires to dispense it
How allocation is recorded while maintaining the study blind
How remaining stock is monitored
How returns and destruction are documented
How emergency unblinding can be performed securely
How each stage is recorded for subsequent review
CRISPNet was developed to connect these additional IMP processes with the wider clinical trial data infrastructure.
Works alongside REDCap and other clinical trial systems
CRISPNet is designed as a flexible IMP-management framework rather than a tool tied exclusively to a single electronic data capture platform.
Where a clinical trial uses REDCap, CRISPNet can be configured to work alongside the study database and support the agreed IMP-management workflows.
The same framework can also be adapted to work with other suitable EDC platforms and research data environments.
Depending on the capabilities and configuration of the underlying systems, CRISPNet may support workflows including:
Participant and treatment allocation
IMP pack selection
Pharmacy notifications
Inventory and stock monitoring
Batch and expiry management
Drug accountability
Automated workflow updates
Emergency unblinding
Cross-system notifications and reporting
Each implementation is assessed individually according to the study requirements, security needs, data flows and governance arrangements of the participating organisations.
This means research teams are not necessarily required to adopt a completely new clinical trial platform simply to access CRISPNet's IMP-management functionality.
CRISPNet can form a specialist IMP-management layer alongside an organisation's existing clinical trial data infrastructure.
Build your own database with CRISPNet-ready templates
Research teams that prefer to design and manage their own clinical trial database can use AGC DATA-provided templates and integration specifications to ensure compatibility with CRISPNet.
These templates can define the minimum required:
Variables
Field names
Identifiers
Data formats
Status fields
Allocation fields
IMP records
Data structures
Workflow requirements
This allows research teams to retain control of their own EDC build while ensuring that the database is structured appropriately for CRISPNet implementation.
Where required, AGC DATA can also review the completed database structure before implementation and provide guidance on any changes needed to support the agreed IMP-management workflows.
This provides three broad ways to work with AGC DATA:
Full database design
AGC DATA designs the clinical trial database externally and provides an import-ready database structure for your organisation to deploy within its own approved environment.
Collaborative database development
AGC DATA works with your research or data-management team to define the required structure, workflows and system requirements.
Self-build with CRISPNet templates
Your team designs and manages the database using AGC DATA-provided templates and technical specifications to maintain compatibility with CRISPNet.
A practical alternative to fully bespoke CTIMP platforms
Many research teams require sophisticated CTIMP functionality but do not need — or have the budget for — a completely bespoke all-in-one clinical trial platform.
AGC DATA takes a modular approach.
Your clinical database can be built using an appropriate existing EDC environment, while CRISPNet adds specialist IMP-management functionality only where it is required.
This approach can provide:
A database designed around your protocol
Familiar data-collection tools for research teams
Specialist IMP-management workflows
Reduced reliance on manual spreadsheets
Improved traceability
Automation of repetitive processes
Clearer oversight for research and pharmacy teams
Infrastructure that can evolve with the study
Greater flexibility in the choice of EDC platform
The aim is to provide the level of functionality your CTIMP actually requires without paying for unnecessary features or commissioning an entirely bespoke platform from the ground up.
Specialist CTIMP database and IMP-management infrastructure, without the fully bespoke price tag.
Designed to support compliant CTIMP delivery
The specific compliance and validation approach for every study depends on its regulatory context, sponsor responsibilities, hosting environment and organisational procedures.
AGC DATA can design systems with controls including:
Role-based permissions
Multi-factor authentication
Restricted access to unblinded information
Automated data validation
Traceable system activity
Controlled system interactions
Regional hosting
Documented system testing
User acceptance testing
Change control
These controls are designed to support the development of reliable, validation-ready clinical trial infrastructure that can be operated within the sponsor's wider quality and regulatory framework.
No software platform alone creates regulatory compliance. The final compliance position depends on the complete system, its hosting environment, validation, documentation, procedures and the way it is operated by the organisations responsible for the study.
Example CTIMP workflow
A typical integrated workflow may include:
1. Participant randomisation
The participant reaches the appropriate stage of the study, and a treatment allocation is generated.
2. IMP selection
CRISPNet identifies an appropriate IMP pack based on treatment allocation, participating site, stock status and relevant expiry criteria.
3. Pharmacy notification
The authorised pharmacy team receives the information required to manage dispensing.
4. Accountability
The allocation is recorded within the agreed study accountability workflow.
5. Inventory monitoring
Available stock and expiry information are monitored, with notifications triggered when intervention is required.
6. Ongoing IMP management
Dispensing, returns and destruction can be recorded according to the agreed study workflow.
7. Emergency unblinding
Where clinically necessary, authorised personnel can access a restricted unblinding workflow without exposing treatment information to the wider blinded study team.
The exact workflow is configured according to the study protocol and the systems approved for use by the sponsor and participating organisations.
Example: MAC-Endo
For the MAC-Endo CTIMP, a connected data infrastructure was developed to support a Phase II, single-centre, double-blind, placebo-controlled clinical trial.
The solution brought together clinical trial data and IMP-management workflows, including:
Block randomisation
Blinded treatment allocation
IMP pack management
Pharmacy workflows
Inventory monitoring
Drug accountability
Emergency unblinding
Automated data-quality processes
CRISPNet provided the IMP-management and automation layer alongside the study's clinical data infrastructure, reducing repetitive manual processes and giving authorised study and pharmacy teams clearer oversight of trial activity.
Read the full MAC-Endo case study
Frequently asked questions
Can REDCap be used for a CTIMP?
Potentially, yes, but REDCap alone does not automatically provide every component required for complete CTIMP and IMP management.
The suitability of a REDCap system for a particular CTIMP depends on the organisation's REDCap environment, governance, validation approach and the specific requirements of the study.
The sponsor and organisation responsible for the REDCap installation should determine whether their environment is suitable for the proposed use and what additional infrastructure is required.
Can AGC DATA build our REDCap database?
AGC DATA can design the database structure externally and provide an import-ready REDCap data dictionary and supporting project specification.
Your organisation can then review, import, host and manage the database within its own REDCap environment.
Where direct access to an institutional REDCap environment is required, this would be subject to that organisation's own governance, access policies and approval.
Can we build the database ourselves?
Yes.
Research teams that prefer to manage their own database development can use CRISPNet-ready templates and integration specifications provided by AGC DATA.
This allows your team to retain control of the EDC build while ensuring that the necessary variables and structures are available to support the agreed CRISPNet workflows.
Does CRISPNet only work with REDCap?
No.
CRISPNet is designed as a flexible IMP-management framework and can be configured to work alongside REDCap or other suitable clinical trial data environments.
The exact implementation will depend on the capabilities of the underlying system, the requirements of the study and the governance arrangements of the participating organisations.
Can REDCap manage IMP stock?
REDCap can be configured to capture and manage structured data, but a complete IMP-management workflow may require additional processes for pack selection, allocation, inventory monitoring, expiry management and accountability.
CRISPNet was developed to provide this additional IMP-management layer.
What is the difference between randomisation and IMP allocation?
Randomisation determines the treatment group to which a participant is assigned.
IMP allocation determines the specific investigational medicinal product or pack that should be dispensed to fulfil that treatment assignment.
In blinded studies, these processes must work together while ensuring that treatment information is only available to appropriately authorised users.
Can CRISPNet support emergency unblinding?
Yes.
CRISPNet can provide a restricted and traceable emergency-unblinding workflow designed to allow appropriately authorised personnel to access treatment information where clinically necessary.
The specific process is configured according to the study protocol and sponsor requirements.
Is CRISPNet part of REDCap?
No.
CRISPNet — the Clinical Research IMP Supply & Processing Network — is an independent IMP-management framework developed by AGC DATA.
It is designed to work alongside REDCap and other suitable clinical trial data environments, subject to the technical, governance and approval requirements of the organisations involved.
Platform notice: REDCap is a third-party electronic data capture platform developed by Vanderbilt University. AGC DATA and CRISPNet are independent of and are not endorsed by Vanderbilt University or the REDCap Consortium. Where REDCap is used, the hosting institution remains responsible for its REDCap environment, licence, governance and access arrangements.
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Brochure
Download the CRISPNet brochure for an overview of its IMP-management capabilities and how it can be integrated with your clinical trial database.
