Journal article
Developing a process for assessing the safety of a digital mental health intervention and gaining regulatory approval: a case study and academic’s guide
- Abstract:
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Background: The field of digital mental health has followed an exponential growth trajectory in recent years. While the evidence base has increased significantly, its adoption within health and care services has been slowed by several challenges, including a lack of knowledge from researchers regarding how to navigate the pathway for mandatory regulatory approval. This paper details the steps that a team must take to achieve the required approvals to carry out a research study using a novel d...
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- Publication status:
- Published
- Peer review status:
- Peer reviewed
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- Files:
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(Preview, Version of record, pdf, 1.2MB, Terms of use)
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- Publisher copy:
- 10.1186/s13063-024-08421-1
Authors
Bibliographic Details
- Publisher:
- BioMed Central
- Journal:
- Trials More from this journal
- Volume:
- 25
- Issue:
- 1
- Article number:
- 604
- Publication date:
- 2024-09-10
- Acceptance date:
- 2024-08-21
- DOI:
- EISSN:
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1745-6215
Item Description
- Language:
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English
- Keywords:
- Source identifiers:
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2250961
- Deposit date:
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2024-09-10
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