Reference:USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020 Q15: Difference between revisions
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| | |has_document=Document:USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020 | ||
| | |module=4 | ||
| | |unit=4.3.4 | ||
| | |scope=G | ||
| | |doc_part=Q15 | ||
| | |language=EN | ||
|entry_by=Florian Adragna | |||
|contributors= | |||
Β | |tags=TAG-00295-Rem-erp ++ TAG-00138-Rem-oni ++ TAG-00320-Foo-eri ++ TAG-00150-Sou-eUr ++ TAG-00137-Mon-che | ||
|tags_display=[[Glossary:TAG-00295-Rem-erp|Remote SDV]], [[Glossary:TAG-00138-Rem-oni|Remote monitoring]], [[Glossary:TAG-00320-Foo-eri|FDA]], [[Glossary:TAG-00150-Sou-eUr|Source documents]], [[Glossary:TAG-00137-Mon-che|Monitoring]] | |||
Β | |comment=Created to be valid during COVID-19 pandemic. | ||
|content=Q15. I am a study monitor and am unable to conduct on-site monitoring visits due to the COVID-19 public health emergency. May I remotely perform the site monitoring visit? What recommendations does FDA have for how I can remotely perform source document review? | |||
| | |||
| | |||
Β | |||
Q15. I am a study monitor and am unable to conduct on-site monitoring visits due to the COVID-19 public health emergency. May I remotely perform the site monitoring visit? What recommendations does FDA have for how I can remotely perform source document review? | |||
[...] | [...] | ||
FDA understands that there may be deviations from the timing of on-site monitoring visits set forth in the trial monitoring plan and procedures, and that sponsors may consider ways to replace on-site monitoring visits with remote monitoring visits during the COVID-19 public health emergency. Further, there may be components of an on-site monitoring visit, as outlined in the trial monitoring plan, that cannot be completed remotely. | FDA understands that there may be deviations from the timing of on-site monitoring visits set forth in the trial monitoring plan and procedures, and that sponsors may consider ways to replace on-site monitoring visits with remote monitoring visits during the COVID-19 public health emergency. Further, there may be components of an on-site monitoring visit, as outlined in the trial monitoring plan, that cannot be completed remotely. | ||
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In addition, processes and procedures should be established for the handling of source document copies that were placed in temporary storage locations for remote review and that are no longer needed after the remote monitoring has concluded. | In addition, processes and procedures should be established for the handling of source document copies that were placed in temporary storage locations for remote review and that are no longer needed after the remote monitoring has concluded. | ||
[...] | [...] | ||
}} | |||
Revision as of 12:56, 16 July 2026
| Document information | |
|---|---|
| Reference | USA FDA Guidance for Industry -
Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020 |
| Validity area | USA |
| Scope(s) | G |
| Document name | FDA Guidance for Industry -
Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency |
| Version / Revision | Mar-2020 |
| Status | Superseded / Invalid |
| Document type | Official recommendation |
| Language(s) | EN |
| Description | Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
Guidance for Industry, Investigators, and Institutional Review Boards |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 4 β Unit 4.3.4 |
| Scope | G |
| Document part | Q15 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Remote SDV, Remote monitoring, FDA, Source documents, Monitoring |
Content
Q15. I am a study monitor and am unable to conduct on-site monitoring visits due to the COVID-19 public health emergency. May I remotely perform the site monitoring visit? What recommendations does FDA have for how I can remotely perform source document review? [...] FDA understands that there may be deviations from the timing of on-site monitoring visits set forth in the trial monitoring plan and procedures, and that sponsors may consider ways to replace on-site monitoring visits with remote monitoring visits during the COVID-19 public health emergency. Further, there may be components of an on-site monitoring visit, as outlined in the trial monitoring plan, that cannot be completed remotely. [...] Remote monitoring should be focused on review of critical study site documentation and source data. [...] β’ If the site can provide appropriate resources and technical capabilities, consider establishing a secure remote viewing portal that would permit site staff to provide access to the siteβs study documentation and/or trial participantsβ source documents for the study monitorβs review. In addition, the potential for remote access to trial participantsβ electronic health records may be explored with trial sites.
β’ Sites could upload certified copies of source records to a sponsor-controlled electronic system or other cloud-based repository that contains appropriate security controls. In the setting of a blinded or partially blinded study, if source documents contain potentially unblind information, controls to protect the study blind should be in place prior to transfer of source documents (e.g., use of an unblinded study monitor to review source documents, restricted access to folders containing copies of source documents). It is not necessary for the clinical site to have control of certified copies of source documents uploaded to such a repository; however, the clinical investigator should maintain control of the original source records. [...] In addition, processes and procedures should be established for the handling of source document copies that were placed in temporary storage locations for remote review and that are no longer needed after the remote monitoring has concluded. [...]
