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patient_registries [2016/06/07 16:42] jillian_nadette_de_leon |
patient_registries [2016/06/07 16:56] jillian_nadette_de_leon |
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| //Registry Design// | //Registry Design// | ||
| * Registries shall be developed with clear and precisely defined purpose to avoid both ethical and compliance issues that may undermine the achievement of the registry's objectives.\\ | * Registries shall be developed with clear and precisely defined purpose to avoid both ethical and compliance issues that may undermine the achievement of the registry's objectives.\\ | ||
| + | * A governance structure for registries shall be formalized to ensure accountability, oversee resource application, provide focus and optimize output from registries. \\ | ||
| + | * All personnel involved in the use of registries must be familiar and abide with administrative and legislative requirements.\\ | ||
| + | * All methods involved in the registry such as but not limited to data collection, data reporting, and addressing of outliers shall be documented.\\ | ||
| + | * A security assessment approach shall be employed to identify measures to be taken to address any identified security gaps.\\ | ||
| //Informed Consent// | //Informed Consent// | ||
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| * Data elements shall conform to standard definitions, terminologies and specifications. It must be used to enable meaningful comparisons and allow maximum benefit to be gained from linkage to other registries and/or databases.\\ | * Data elements shall conform to standard definitions, terminologies and specifications. It must be used to enable meaningful comparisons and allow maximum benefit to be gained from linkage to other registries and/or databases.\\ | ||
| * Data dictionaries shall be established to ensure that a systematic identical approach is taken during data collection and data entry.\\ | * Data dictionaries shall be established to ensure that a systematic identical approach is taken during data collection and data entry.\\ | ||
| + | * Registry reports shall be produced according to a strict timeline.\\ | ||
| * For data previously collected, the privacy conditions under which they were collected shall be set as the minimum privacy conditions.\\ | * For data previously collected, the privacy conditions under which they were collected shall be set as the minimum privacy conditions.\\ | ||
| + | * Audit of registry data shall be done frequently to promptly identify data quality lapses.\\ | ||
| //Data Collection// | //Data Collection// | ||
| * Data collection shall be done in a systematic approach, with identical approaches used at different institutions ensuring that it shall not be an unreasonable burden to patients, nor incur any cost. \\ | * Data collection shall be done in a systematic approach, with identical approaches used at different institutions ensuring that it shall not be an unreasonable burden to patients, nor incur any cost. \\ | ||
| * Collection of data shall be done as close as possible to the time and place of care by appropriately trained data collectors.\\ | * Collection of data shall be done as close as possible to the time and place of care by appropriately trained data collectors.\\ | ||
| + | * Registry participants or their next of kin shall be made aware of the collection of data. | ||
| //Registry data for Research Purposes// | //Registry data for Research Purposes// | ||