Table 3 Categories and features for operational management of clinical trials

Subject management

Study participants assignment

Assigns study project participants (such as investigators, study nurses, clinical research coordinator (CRC), and clinical research associate (CRA)) and sets corresponding permissions

Protocol configuration

The protocol is mapped to computational executable events; the study plan can be automatically generated according to the visit cycle

Rule configuration

Configures rules required for subject management (such as inclusion and exclusion criteria, various number generation rules, and drug randomization methods)

Running projects list

Contains responsible or participating running clinical trial projects, with access management

Subject list

Contains a list of subjects recruited for this study project, with different colors to distinguish the status of subjects

Subject recruitment

Subjects’ information can be linked by searching the hospital’s patient database and alerted if they are enrolled in other clinical trials

Subject study process management

Manages the entire process of subjects from recruitment to the end of the visit, performs the study content required in the corresponding visit cycle (such as screening, randomization, inspection, and investigational product), and can query all the data required for clinical trials

Study progress statistics

Generates statistics based on the distribution of subjects in different dimensions, including recruitment date, visit cycle, and different states (drop out, withdraw, completion, etc.)

Investigational product management

Stock management

Manages the inbound, storage, outbound, and refund of investigational product; the inventory quantity can be classified and counted by dictionary, batch, and random code

Prescription management

Manages the closed-loop process of prescription issuance, verification, distribution, use, and refund of investigational product, and supports different blinding methods (such as open, single-blinding, and double-blinding), which can be traced

Label management

All circulation links of investigational product support automatic label scanning and verification (including inbound, outbound, use, etc.)

Intelligent detection

Intelligent early warning and verification of the management process of investigational product (such as near expiration date early warning, inventory early warning, and rule-based verification)

Financial management

Payment and allocation management

Manages the financial process of payment addition, allocation (such as subject fee, investigator fee, and inspection fee), review, etc

Budget management

Manages the budget associated with the study project, including budget list, budget summary, and budget adjustment

Expenditure management

Manages all kinds of expenses and related study project funds

Workload statistics

Counts the corresponding workload in different dimensions (such as executive departments, project contracts, billing departments, and cost accounting) to produce financial statements

Project funding amount

Manages the summary and detailed list of various expenses of study projects (such as subject fee, investigator fee, and inspection fee)

Quality management

Quality control data reporting

Manages the reporting of various quality control data (such as mid-term study quality control, study monitoring, study audit, and site audit)

Quality control element capture

Automatically obtains corresponding quality control elements during clinical trial running (such as deviation protocol, out of visit window, and adverse events)

Operational data query

With authorization, the quality controller can query the running data of the study project in real-time