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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 | rcc.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.

<META> KEYWORDS

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 | rcc.tech-res.com Reviews

https://rcc.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

rcc.tech-res.com

1

DAIDS Regulatory Support Center - Broadcast Memos

http://rcc.tech-res.com//broadcastmemos

Web Site Update Log. Human Subjects Protection (HSP). Need Help Developing Informed Consent Forms for DAIDS Supported and/or Sponsored Studies? Informed Consent Templates Available. DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0, November 2014 Training Presentation Available. Do You Know About HANC? Obtaining access to the DAIDS Adverse Experience Reporting System (DAERS). Update to the DAIDS Protocol Registration (PR) Policy and Manual. Get Answers to Your Questi...

2

DAIDS Regulatory Compliance Center - Case Report Form Management

http://rcc.tech-res.com//casereportformmanagement

Web Site Update Log. Human Subjects Protection (HSP). What does the DAIDS/RSC Case Report Form Management team do? DAIDS has provided instructions (see below) for sending case report forms (CRFs) and pharmacy records to the RSC for transfer to long term storage. The RSC CRF team confirms the inventory provided by the site with the documents received at the RSC before transferring them to the government long-term storage facility. Effective June 14, 2013. CRF Master Inventory List Template. August 16, 2016.

3

DAIDS Regulatory Support Center - About the RSC

http://rcc.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...

4

DAIDS Regulatory Support Center - Safety and Pharmacovigilance

http://rcc.tech-res.com//safetyandpharmacovigilance

Web Site Update Log. Human Subjects Protection (HSP). What does the DAIDS/RSC Safety and Pharmacovigilance team do? Click on a topic below to view detailed information. Manual for Expedited Reporting. EAE and SAE Policy. RSC Safety Information Center. Clinical Trials Agreement Support. Case Report Form Management. Clinical Study Information Office. Latest News and Updates. 2016 Network meeting safety trainings available on the Safety and Pharmacovigilance Training page. August 16, 2016. July 28, 2016.

5

DAIDS Regulatory Support Center - Protocol Development Information

http://rcc.tech-res.com//protocoldevelopmentinformation

Web Site Update Log. Human Subjects Protection (HSP). Click here to view the Drug Risk List Table. Division of AIDS Risk Worksheet Guidelines. DAIDS Risk Worksheet Guidelines. DAIDS Protocol Risk Worksheet. DAIDS Protocol Risk Ranking Data Capture and Distribution Standard Operating Procedure. Lifecycle of a Protocol. This document must be viewed using Adobe Acrobat Reader or Adobe Acrobat Pro. Letter of Amendment Flowchart. DAIDS Guidance for Implementing Protocol Changes. Effective April 12, 2010).

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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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