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DAIDS Regulatory Support Center

Web Site Update Log. Human Subjects Protection (HSP). For more information about the DAIDS RSC click here. EAE and SAE Policy. RSC Safety Information Center. Clinical Trials Agreement Support. Case Report Form Management. Clinical Study Information Office. Latest News and Updates. The revised versions of the DAIDS Protocol Registration Policy and Manual (effective date of May 27, 2015) were released and links have been posted to the Protocol Registration Page. May 8, 2015. May 4, 2015. March 31, 2015.

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DAIDS Regulatory Support Center | rsc.tech-res.com Reviews
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Web Site Update Log. Human Subjects Protection (HSP). For more information about the DAIDS RSC click here. EAE and SAE Policy. RSC Safety Information Center. Clinical Trials Agreement Support. Case Report Form Management. Clinical Study Information Office. Latest News and Updates. The revised versions of the DAIDS Protocol Registration Policy and Manual (effective date of May 27, 2015) were released and links have been posted to the Protocol Registration Page. May 8, 2015. May 4, 2015. March 31, 2015.
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1 about the rsc
2 frequently asked questions
3 contact information
4 useful links
5 broadcast memos
6 tutorials and tools
7 regulatory information
8 protocol development information
9 protocol registration
10 safety and pharmacovigilance
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about the rsc,frequently asked questions,contact information,useful links,broadcast memos,tutorials and tools,regulatory information,protocol development information,protocol registration,safety and pharmacovigilance,case report form,crf management
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DAIDS Regulatory Support Center | rsc.tech-res.com Reviews

https://rsc.tech-res.com

Web Site Update Log. Human Subjects Protection (HSP). For more information about the DAIDS RSC click here. EAE and SAE Policy. RSC Safety Information Center. Clinical Trials Agreement Support. Case Report Form Management. Clinical Study Information Office. Latest News and Updates. The revised versions of the DAIDS Protocol Registration Policy and Manual (effective date of May 27, 2015) were released and links have been posted to the Protocol Registration Page. May 8, 2015. May 4, 2015. March 31, 2015.

INTERNAL PAGES

rsc.tech-res.com rsc.tech-res.com
1

DAIDS Regulatory Support Center - About the RSC

http://rsc.tech-res.com/aboutRCC.aspx

Web Site Update Log. Human Subjects Protection (HSP). What does the RSC Regulatory Team do? The Regulatory Team reviews Protocol Documents for regulatory compliance, and prepares and files new Investigation New Drug Applications (INDs) and amendments to existing INDs in compliance with the procedural and substantive requirements of 21 CFR 312. Examples of submissions to the FDA include original IND Applications, Annual Reports, Safety Reports, and Responses to FDA Requests for Information. The RSC Safety...

2

DAIDS Regulatory Support Center - Regulatory Information

http://rsc.tech-res.com//regulatoryinformation

Web Site Update Log. Human Subjects Protection (HSP). Click here for information on ClinicalTrials.gov and FDAAA. What does the DAIDS/RSC Regulatory team do? NIAID’s ClinRegs website is a central resource for exploring and comparing international clinical research regulations. DAIDS Review of Informed Consent Forms: Impact of the HIPAA Privacy Rule. DAIDS Policy # DWD-POL-CL-013.03, Expedited Adverse Event Reporting, dated 28 April 2010. Latest DAIDS Policies and SOPs. National Institutes of Health (NIH).

3

DAIDS Regulatory Support Center - IMPORTANT LINKS FOR DAIDS CLINICAL RESEARCH SITES

http://rsc.tech-res.com/siteinfo.aspx

Web Site Update Log. Human Subjects Protection (HSP). Entering/updating your site personnel and contact information in the DAIDS-Enterprise System (DAIDS-ES)? Visit the Clinical Study Information Office (CSIO). Page or the Tutorials and Tools. How CRS Coordinators can Run the CRS Profile Report and Update Site Personnel in the DAIDS-ES. Registering your site to a DAIDS protocol? Visit the Protocol Registration. Protocol Registration at a Glance 2012. DPRS Quick Reference Guide. Final 2.0, January 2010.

4

DAIDS Regulatory Support Center - About the RSC

http://rsc.tech-res.com//aboutrsc.aspx

Web Site Update Log. Human Subjects Protection (HSP). What does the RSC Regulatory Team do? The Regulatory Team reviews Protocol Documents for regulatory compliance, and prepares and files new Investigation New Drug Applications (INDs) and amendments to existing INDs in compliance with the procedural and substantive requirements of 21 CFR 312. Examples of submissions to the FDA include original IND Applications, Annual Reports, Safety Reports, and Responses to FDA Requests for Information. The RSC Safety...

5

DAIDS Regulatory Support Center - Safety and Pharmacovigilance - Expedited Reporting - DAERS

http://rsc.tech-res.com/safetyandpharmacovigilance/expeditedreportingdaers.aspx

Web Site Update Log. Human Subjects Protection (HSP). Frequently Asked Questions (FAQs). Submitting Adverse Events via DAERS:. Https:/ ncrms.niaid.nih.gov/. DAERS - How to Report and Submit. Phone: 1 (800) 537-9979 (USA toll-free). Or 1 (301) 897-1709 (Outside USA). DAERS - IT Support. Phone: 1 (240) 778-2517. DAERS Emergency Information - Frequently Asked Questions. DAERS - Request Training at. DAERS Access User Guide for EAE Reporter and Submitter Rights. DAERS Reference Guide for Site Enrollment Users.

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LINKS TO THIS WEBSITE

daidscrss.com daidscrss.com

https://www.daidscrss.com/Regulatory%20Management

Turn on more accessible mode. Turn off more accessible mode. Skip to main content. This page location is:. Laboratory Management Documents Login. DAIDS HIV Research Counseling and Training. DAIDS Protocol Registration Training. Quality Management Training Program. DAIDS Critical Events Training. DAIDS Regional Training Events (DRTEs). DAIDS Learning Management System. Download Adobe Acrobat Reader. For more information on the DAIDS RSC, please use the following link:. Http:/ rsc.tech-res.com/.

impaactnetwork.org impaactnetwork.org

IMPAACT Regulatory Resources

http://www.impaactnetwork.org/resources/regulatory-resources.htm

Submit a Study Proposal. External and Regulatory Resources. Network Templates and Logos. External and Regulatory Resources. Network Templates and Logos. External and Regulatory Resources. DAIDS Regulatory Compliance Center (RSC). Regulatory resources, including AE reporting manuals and forms, protocol registration materials, and toxicity tables, are available on the RSC website. Instructional videos have been posted to the RSC Website. Visit the HANC page. International Conference on Harmonization Website.

uz-ucsf.co.zw uz-ucsf.co.zw

Links and Resources | UZ-UCSF

http://www.uz-ucsf.co.zw/resources

Our Mission, Goals, and Core Values. Collaborating Institutions & Acknowledgements. Laboratory & Pharmacy. Research & Publications. World Health Organization Regional Office for Africa. US National Institutes of Health Protecting Human Research Participants. US National Institutes of Health Division of AIDS Office of Clinical Site Oversight (OCSO). US National Institutes of Health Division of AIDS. US National Institutes of Health DAIDS Learning Management System (DAIDS LMS). UCSF Safe Motherhood Program.

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DAIDS Regulatory Support Center

Web Site Update Log. Human Subjects Protection (HSP). For more information about the DAIDS RSC click here. EAE and SAE Policy. RSC Safety Information Center. Clinical Trials Agreement Support. Case Report Form Management. Clinical Study Information Office. Latest News and Updates. The revised versions of the DAIDS Protocol Registration Policy and Manual (effective date of May 27, 2015) were released and links have been posted to the Protocol Registration Page. May 8, 2015. May 4, 2015. March 31, 2015.

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