1 | Implement security measures and protocols that prohibit unauthorised access to the study and data. |
2 | Provide adequate audit trail to ensure that all changes pertaining to the conduct of the trial are well documented. |
3 | Incorporate features to encourage the consistent use of clinical terminology and to alert users that data is out of range. |
4 | Provide suitable safeguards to isolate identifiable information from the study and ensure that retrieved data regarding each subject is only attributable to that subject. |
5 | Provide satisfactory backup and recovery protocols to guard against data loss. |
6 | Provide support for several types of fields (such as dates, text, numerical values) and in various formats (such as files, x-ray images). |
7 | Facilitate data extraction and the ability to swiftly generate reports. |
8 | Uphold the cost effectiveness of the system. |
9 | Endorse minimal development efforts |
10 | Advocate an advantageous type of licensing. |
11 | Promote adherence to industry standards, such as the Clinical Data Interchange Standards Consortium (CDISC) |