Clinical Trial Data Management Software Development

Protocol record capturing the study design, primary and secondary endpoints, visit schedule, inclusion and exclusion criteria, randomisation scheme, and safety monitoring requirements. eCRF design configured to the study protocol, with each visit's data collection forms built from the protocol visit schedule and the data collection requirements for each visit. Form-level and field-level validation rules enforcing the data quality requirements defined in the protocol -- required fields, range checks, date logic, and cross-field consistency checks. Conditional form display where subsequent questions or fields are shown or hidden based on prior answers. Protocol amendment management recording changes to the study design after enrolment starts, with version control on the protocol and eCRF and impact assessment on enrolled subjects' data.

Subject screening record capturing the screening visit data and eligibility assessment against the protocol inclusion and exclusion criteria, with the eligibility determination recorded and the screen failure reason documented for screen failures. Subject enrolment confirmation requiring the eligibility determination to be completed before the subject is assigned a study number and randomised. Randomisation using the scheme defined in the protocol -- simple, stratified, or minimisation -- with the randomisation list managed centrally and treatment assignment concealed from the investigator site until the point of assignment. Enrolment tracking by site showing current enrolment against target, screen failure rate, and enrolment rate for trial management. Subject withdrawal recording with the withdrawal reason, the date, and the last completed visit. Subject status dashboard showing the current status of every enrolled subject across all sites in real time.

eCRF completion by site coordinators through a web application accessible from any device at the investigator site, with offline capability for sites with unreliable internet access. Data entry progress tracking showing which visit forms are complete, incomplete, or outstanding for each subject at each site. Automated query generation when a field value fails validation -- range out of expected bounds, date inconsistency, required field left blank -- with the query displayed to the site coordinator for resolution. Manual query raising by the data management team for data issues that require investigator review. Query response and closure workflow with the query, the response, and the resolution recorded in the audit trail. Data freeze workflow at study close-out preventing further data entry once the database lock has been initiated, with the locked data version retained for submission.

Adverse event recording in structured fields covering event description, MedDRA coding, onset date, resolution date, severity, relationship to study treatment, and outcome. SAE identification with automatic flagging when the reported event meets the seriousness criteria defined in the protocol. SAE notification workflow triggering the sponsor safety reporting process with regulatory timeline tracking -- 7-day expedited reporting for fatal or life-threatening unexpected SAEs, 15-day reporting for other unexpected SAEs -- with the notification status visible to the pharmacovigilance team. Sponsor safety database integration for transmission of SAE data to the sponsor's global safety database without re-entry. Safety data aggregate view for DSMB or safety review committee, showing AE frequency by system organ class and MedDRA preferred term across all sites and all subjects.

Investigator site file management with the essential documents required for site initiation, ongoing operation, and close-out organised by ICH E6 section and status-tracked for completeness. Monitoring visit scheduling and record management, with the monitoring visit report linked to the site record and findings recorded with corrective action assignment and closure. Protocol deviation recording and categorisation -- major, minor, or potential -- with regulatory reporting determination and corrective action workflow. Site initiation, interim monitoring, and close-out visit scheduling with calendar integration and automated reminder. Investigator and site personnel training record management, showing current training status and recording completion of protocol-specific and GCP training for each site personnel member.

SDTM domain mapping configured during the project to map the study's eCRF data fields to the appropriate CDISC SDTM domain variables, using the controlled terminology and coding conventions required for FDA and EMA submission. SDTM dataset generation from the locked study database, producing the domain datasets -- DM, AE, CM, EX, LB, VS, and study-specific domains -- in the SAS XPORT or CSV format required for submission. Define-XML production documenting the dataset structure, variable labels, and controlled terminology for the submission. ADAM dataset derivation for analysis datasets required by the statistical analysis plan. Submission package review capability to validate the SDTM and ADaM datasets against the CDISC validation rules before submission, identifying issues that FDA reviewers would find. The submission data that arrives at the agency ready for review rather than requiring a complete transformation effort after the trial ends.