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| name | 20190114_D1.1 Educational resources and guidelines for members related the implementation of the GRID_WMDA.pdf |
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| height | 250 |
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B | 5 | 5 | | We need to reorder the session | B | 5 | | System Documentation | B | 5 | 5.01 | The registry must maintain activity records of its activities and must maintain a database of volunteer donor information. | Any registry system must be accompanied with adequate documentation detailing its specification, validation, maintenance, administration and operation; including hardware, software, the network architecture and external connections. | Moved to 5.10 | B | 5 | 5.01.1 | The donor centre/cord blood bank must use a validated process for transmitting donor data/cord blood unit information necessary for search process to the registry. | Move to 5.15 | System Security | B | 5 | 5.02 | Any HLA-related information stored, presented or communicated by the registry must follow WMDA guidelines for the use of HLA nomenclature. | Electronic connection and communication between organisations must be coordinatedand performed with greatest possible care minimizing vulnerabilities and exploitation risks. | Business Continuity | B | 5 | 5.03 | All patient and donor communications and records must be stored to ensure confidentiality and to allow for traceability of the donors/cord blood units and steps of the donation process. | Redundant, reliable software and hardware architecture should be used to minimisethe probability of failure or data loss and the possible length of a down time. | Move to 5.11 | B | 5 | 5.04 | x | To ensure confidentiality, the identity of donors/cord blood units must be protected. The registry, or its designee, must assign a unique and anonymous identifier to each volunteer donor, each maternal donor and each cellular product. This identifier must be used to track each volunteer donor and cord blood unit with their associated data and biological material and their participation in the donation process long term. | Backup of all systems and data must be performed regularly at reasonable intervals. Backups must be validated by data restoration tests. These activities must be documented. | B | 5 | 5.04.1 | The registry should use GRID to issue donor identifiers. If the registry has not fully implemented the GRID, an implementation plan for the usage of GRID as a unique donor identifier should be in place. | Move to 5.16 | B | 5 | 5.05 | The system of quality management must include an assessment of all electronic functions to ensure that errors and problems are reported and resolved. | In the event of termination of operations, the registry must ensure continued adherence to data protection and record retention standards. This may be accomplished through transference of these data, records and associated responsibilities, to a qualified organisation. | Moved to 5.06 | Maintenance | B | 5 | 5.06 | The access to donor and patient data information in the registry as well as the transmission of this information to and from the registry must be organised in a way that accidental or unauthorised access, destruction or modification is prevented. | The system of quality management must include an assessment of all electronic functions to ensure that errors and problems are reported and resolved. | B | 5 | 5.07 | Records must be maintained for an appropriate period of time, at least as dictated by national laws or standards. Key documents related to donor traceability must be maintained at a minimum for thirty (30) years following donation. Data storage may be on paper or in electronic form. | System modifications must be managed through a documented change management process. | B | 5 | | B | 5 | 5.08 | The key components of a registry’s hardware, software and network architecture and external connections must be adequately documented. | Registry information technology systems must be maintained to ensure that the used software is up to date to minimize security risks and to make sure that all systems are running properly. | Moved to 5.01 | Software Development | B | 5 | 5.09 | Electronic connection and communication between establishments must be organised and performed with greatest possible care minimizing vulnerabilities and exploitation risks. | Registry software developed in-house must follow a documented software development process. This process must cover all the important steps in a software lifecycle process (planning, analysis, design, implementation, testing and integration, maintenance). | Moved to 5.02 | Registry Operations - Traceability | B | 5 | 5.09.1 | When transferring electronic data from the registry to another establishment, there must be a validated protocol for the transfer of data. Both the transferring establishment and the receiving establishment must have policies to validate data. | Move to 5.15 | | B | 5 | 5.10 | x | Redundant and reliable software and hardware architecture should be used to minimise the probability of failure or data loss and the possible length of a down time. | The registry must maintain records of its activities and must maintain a database of volunteer donor and/or cord blood unit information. | Moved to 5.03 |
| B | 5 | 5.11 | x | Backup of all systems and data must be performed regularly at reasonable intervals. Backups must be validated by data restoration tests. These activities must be documented. | All patient and donor/cord blood communications and records must be stored to allow for traceability of the donors/cord blood unitsfrom recruitment through the donation process, and post-donation. | Moved to 5.04 |
B | 5 | 5.12 | The overall system documentation must provide all information necessary for trained and skilled staff to keep the Information Technology systems operational. | Each step in the search process must be documented with all relevant attributes, including a date and time stamp. | Moved to 5.01 | B | 5 | | B | 5 | 5.13 | A procedure for the definition, specification, implementation, validation and authorisation of relevant systems (software, hardware and network) must be established and documented. Each such process itself must be appropriately documented on a continuous basis. | The information history of relevant data must be recorded. | Moved to 5.01 | Operations - Data Transmission | | B | 5 | 5.14 | x | Any system installed must be accompanied with adequate documentation for its qualification, maintenance (in particular detail if developed in house), administration and operation. | The registry must have sufficient communication links to facilitate searches,including backup methods if the principal link is unavailable. | Moved to 5.01 |
B | 5 | 5.15 | Any modifications to such systems must be performed in a way fulfilling 5.13 and 5.14. | When transferring data between organisations, there must be a validated protocol for the transfer of data. Both the transferring organisationand the receiving organisationmust have policies to validate data. | Moved to 5.07 | B | 5 | 5.16 | Any function needed for information management may be performed by or with the help of qualified third parties. Responsibilities of both parties must be described in writing. | The registry listing adult volunteer donors must use GRID to issue donor identifiers at the time that WMDA makes GRID mandatory. | B | 5 | | Operations - Quality | B | 5 | 5.17 | x | Search algorithms must provide lists of suitably matched donors in a reasonable time frame. | Search reports must generate lists of suitably matched donors/cord blood units in a reasonable time frame | B | 5 | 5.18 | x | Each printed report must be dated. | B | 5 | 5.19 | Each step in the search process must be documented with all relevant attributes and a time stamp. | Move to 5.12 | B | 5 | 5.20 | The information history of relevant data must be recorded. | Move to 5.13 | |