Page 179 - Diagnostic delay of endometriosis

Research data management
This thesis is based on the results of human studies, which were conducted in accordance with the principles of the Declaration of Helsinki. The medical and ethical review board Committee on Research Involving Human Subjects Region Arnhem Nijmegen, Nijmegen, the Netherlands has given approval to conduct these studies (File number CMO 2016-2629).
This project is stored on the Radboudumc, department server: (H:) VERLGYNdata$(\\UMCfs049) under Onderzoek.
In our studies, patients and general practitioners received a questionnaire and the written informed consent prior to the start of their focus group. The hard copies were stored in the department archive (Radboudumc, room M325.01.204), closet number 6. Data management and monitoring were also performed within Castor EDC. An audit trail was incorporated to provide evidence of the activities that have altered the original data. Data were converged from Castor EDC to SPSS (SPSS Inc., Chicago, Illinois, USA).
The patient data for the analyses of the studies as presented in chapter 2 and 3 is stored on the departments’ H-drive (H:\VERLGYNdata$(\\UMCfs049)\ Onderzoek\VPG-diagnostic delay endometriosis in SPSS format: Database interview studie patiënten (chapter 2), and in Word format: Focusgroepen patiënt en endometriose\Transcripten (chapter 3). The data for chapter 4, 5, 6 and 7 is stored on the departments’ H-drive (H:\VERLGYNdata$(\\UMCfs049\ Onderzoek\VPG-diagnostic delay endometriosis.
The data will be saved for 15 years after termination of the study (28-03- 2017). Using these patient data in future research is only possible after a renewed permission by the patient as recorded in the informed consent. The datasets analyzed during these studies are available from the corresponding author on reasonable request.
Research data management | 177