Baumgardt, Johanna
Schwarz, Julian
Bechdolf, Andreas
Nikolaidis, Konstantinos
Heinze, Martin
Hamann, Johannes
Holzke, Martin
Längle, Gerhard
Richter, Janina
Brieger, Peter
Kilian, Reinhold
Timm, Jürgen
Hirschmeier, Constance
Von Peter, Sebastian
Weinmann, Stefan
Funding for this research was provided by:
Federal Joint Committee/Gemeinsamer Bundesausschuss (VSF2_2019-108)
Article History
Received: 23 February 2021
Accepted: 11 March 2021
First Online: 30 March 2021
Change Date: 19 April 2021
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1186/s12888-021-03204-3
Declarations
:
: The ethics committee of the Brandenburg Medical School Theodor Fontane (MHB) gave full approval to the AKtiV trial on October 23rd 2020 (E-02-20200715). Ethics committees of all study sites followed this approval. Study participants will be informed about the trial in detail and extensively. Study participation requires consent from the study participant or his/her legal guardian.The AKtiV study design follows the current recommendations of implementation science and the state-of-the-art-regarding the reporting of naturalistic studies [CitationRef removed–CitationRef removed]. It will be conducted in line with the Declaration of Helsinki, the Guidelines and Recommendations for Ensuring Good Epidemiological Practice (GEP) and Good Clinical Practice (GCP), the Memorandum for Ensuring Good scientific Practice (DFG), the CONSORT statement, and the Guideline of the Medical Research Council (MRC). It will follow the ICH-Guideline as well as the quality-assuring Standard Operating Procedures (SOP) of the Competence Center for Clinical Trials (KKSB) of the University of Bremen.All personal data assessed in the trial is subject to medical confidentiality. The data protection officer of the MHB granted full approval to the data assurance concept of the AKtiV trial on October 30th 2020 (“Forschungsprojekt: AKtiV Datenschutzrechtliche Prüfung des Forschungsvorhabens”). The data protection officers of all study sites followed this approval. The data assurance is subject to the provisions of the European General Data Protection Regulation (GDPR) [CitationRef removed], the German Federal Data Protection Act (BDSG) [CitationRef removed], and the Social Security Law Book (SGB).
: Not applicable.
: All authors do declare not to have any competing interest.