Table 1 Description of functions used in the smart contract
CT Stage | Function | Input | Output | Permissions | Description |
|---|---|---|---|---|---|
New Drug Application | INDRequestedBySponsor | Trial phase, trial number, IND Application hashed file | – | Trial Sponsor | File a new drug application request |
SetINDApproval | True/False | Alert | FDA | Approves or rejects the request based on the information provided | |
Clinical Trial Initiation | ClinicalInitiationBySponsor | CT start & completion dates, minimum number of patients needed, CT protocol, SOP & PI’s CV hashed files | – | Trial Sponsor | Request CT initiation |
SetClinicalInitiaionDecision | True/False | Alert | FDA | Approve or reject the request based on the information provided | |
Patient Enrollment | PatientEnrollment | EA of patients enrolled, informed consent & medical history hashed files | – | Physician | Enrol patients that meet the inclusion/exclusion criteria into the trial |
GetPatientInfo | – | Patients EAs | All participants in the network | Returns the address of patients enrolled in the trial | |
GetPatientsDetails | Patient EA | Age, Informed consent & medical history hashed files | Returns the enrollment details about a particular patient address | ||
CountPatients | – | Number of patients enrolled | Returns the total number of patients participating in the trial | ||
EnrollmentStageCompleted | True/False | Alert | Physician | Notifies the participants on the completion of the enrollment stage | |
Patient Monitoring | PatientMonitoring | EA of patients enrolled, CRF, lab results, patient follow-up hashed files | – | Physician, Medical lab scientist | Update the details of patients with each visit |
GetPatientMonitoringDetailPer Visit | Patient EA, visit number | CRF, lab results, patient follow-up hashed files | All participants in the network | Returns the details of a patient based on a particular visit | |
dropPatient | Patient EA | Alert | Physician | Drops the patient from the trial if he/she has discontinued the treatment | |
SAE Occurrence | SetSAEStage | SAE reporting hashed file | – | PI | Reports an occurrence of an SAE event |
SAEApproval | True/False | Alert | IRB | Approves or rejects the request based on the information provided | |
Analysis And Reporting | ReportAnalysisStage | Final clinical reporting hashed file | – | Trial Sponsor | Uploads the final CT findings |
SetCTDecision | True/False | Alert | FDA | Approves or rejects the request based on the information provided |