Data Management SOP Reference: RGIT_SOP_020 Version Number: 10.0 2.2.5 Set security for the directory. x��=Yo�����Q���5�"��k9� Efficient data collection and management is an essential component of a Clinical Trial. User Responsibilities. SOP. trial data collection and management techniques. MACRO 4 is the single data management system that will centralise, automate, streamline and enhance the process of data collection whenever possible (WWORTH SOP 21 IT Databases). 1 0 obj Easily create your GDPR data protection policy using this customisable template Clear and effective policies are a key part of GDPR compliance. CRF template generic. Writing an SOP from scratch can be very tiring and time-consuming. stream endobj Please see full text example DMPs at the bottom of this page. The individual is ultimately responsible for the security of any data that he or she has access to. The information inside a data can be invaluable, and if you lose or misplace them, it might cause some inconveniences. MACRO 4 is the single data management system that will centralise, automate, streamline and enhance the process of data collection whenever possible (WWORTH SOP 21 IT Databases). Blood Sampling SOP. This standard operating procedure (SOP) describes the processes Georgia CORE monitors at sites to ensure the appropriate collection of clinical research data, transcription of the data to case report forms (CRFs), and the management of the data. H2020 templates: Data management plan v2.0 – 15.02.2018 1 TEMPLATE HORIZON 2020 DATA MANAGEMENT PLAN (DMP) Annotated version for the use of participants under Societal Challenge 1 Instructions and footnotes in blue must not appear in the text. The present Data Management Quality Manual follows the International Organization for Standardization (ISO) standards. Staff should collaborate to prevent the storage of duplicate data assets, wherever possible referring to an organisational single source of truth rather than saving a local copy. These SOP's have since been updated and harmonized by James Smedley and Yves Claeys to present the first version at the 3rd DM Workshop in Varanasi, India (2013). The following . <>>> shall be responsible for implementation and compliance of the SOP. 2 0 obj 5.3 Any identified data integrity issue shall be handled as per the quality management system and proper corrective and preventive action shall be taken according to risk assessment. A template structure Numbered and titled Added to the document management system (DMS) Signed off by management; Used in daily operation; Regularly reviewed and updated Archived when no longer necessary. Every good inventory management process needs to have some sort of unique identifier to keep everything organized. J4��˪V�����������+ �B�#}�������$c%�^��R��q.�%S���� �be-�бR3a�}3������6��*리e�*o���H-n�Gf�e)��߽_��ff4�������[�qF%Z��ji\�7����%j��9ҋ�K3�2L�{ׅ��J�ZE |��k��ԋ�ޢ.>�"�[�����Ov����/�� +��k�#����;o���J��u%F�US�����H�_3&^. This PDF works as both a template and a guide to risk assessing your standard operating procedures and further risk management. A certificate of calibration must be kept on file. Provide general introductory text as to the purpose of the clinical data management plan (CDMP) including its central role in making explicit to all stakeholders specific information regarding the data management practices needed to ensure appropriate handling of data at all steps of the project to assure a high-quality database at the end of the study, ready for analysis. TEMPLATE WITH INSTRUCTIONS AND EXAMPLES. CRF tracking template : Study and Site Management : Trial contacts sheet. • If your state-supplied data logger is broken, call the Vaccine Management Unit for immediate replacement. 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