RSC Safety Information Center (RIC) Frequently Asked Questions

The RSC Safety Information Center (RIC) cannot add recipients for safety information that do not have a role defined by the DAIDS-approved distribution algorithm. Per DAIDS procedures, the safety information is distributed to CTU Principal Investigators, CRS Site Leaders, Investigators of Record, CTU/CRS Coordinators, Study Chairs, Co-chairs and Vice Chairs only, as identified in NIAID Clinical Research Management System (NCRMS) . If individuals assigned to these roles at the site change, contact the Office of Clinical Site Oversight (OCSO) representative for that site who can have that change made. Any personnel changes to authorized recipients for NICHD funded sites need to be made through Westat.

The distribution of safety information is drug and study site specific so it is not possible for the RSC to add individuals who are not associated with the roles identified above. There are, however, ways in which rules can be created in Microsoft Outlook which will automatically forward documents received from a particular address (such as the RSC Safety Information Center) to others at your site. Other e-mail systems have similar capabilities. The IT Support group at your institution can probably assist you. Here are a few helpful links for Microsoft Outlook to create rules which will assist you in the distribution of the e-mailed documents within your site:

Microsoft Outlook support site: https://support.microsoft.com/en-us/kb/829918

Per DAIDS procedures, Study Chairs, Co-Chairs and Vice Chairs will only receive Investigator’s Brochures supporting the studies for which they are identified as Study Chairs, Co-Chairs and Vice Chairs in NIAID Clinical Research Management System (NCRMS). The RSC Safety Information Center (RIC) cannot add recipients for safety information that do not have a role defined by the DAIDS-approved distribution algorithm. Study Chairs, Co-chairs and Vice Chairs can be provided the IB upon request.

The DAIDS-approved distribution algorithm for safety reports (Safety Memos, IND Safety and MedWatch Reports) includes protocols that are in development. This enables DAIDS to provide relevant safety information to the DAIDS Medical Officers and Protocol Team during the development of new protocols. Per DAIDS, until the site is registered to a protocol, the site is not responsible for sending reports related to the protocol to the Institutional Review Board (IRB).

Due to the confidential nature of the document, the CRS Leader, CRS Coordinator, Study Chairs, Co-chairs and Vice Chairs should acknowledge the IB by either accepting or declining the confidentiality agreement. The IB will be available in the NCRMS EAE Reporting Module after accepting the confidentiality agreement. If the confidentiality agreement is declined, then the IB will not be available.

If you receive a notification of a V1.0 IB distribution and will be participating in the study, send in your request to RIC within 3 business days. Any requests received after 3 business days will result in a delay in receiving the IB, which will be processed within 5 business days of the request. For more details please refer to FAQ on “How do I request access to Investigator's Brochure (IB)?” below.

Due to confidential nature of the document, the CRS Leader, CRS Coordinator, Study Chairs, Co-chairs and Vice Chairs should acknowledge the IB by either accepting or declining the confidentiality agreement. The IB will be available in the NCRMS EAE Reporting Module after accepting the confidentiality agreement. If the confidentiality agreement is declined, then the IB will not be available.

Only the IBs distributed from the launch of the program (September 17, 2018) will be available and displayed through the interface. All IB documents distributed prior to the launch were distributed to the CRS Leaders on CD and should be maintained at the site. If an IB document cannot be located at the site, a request for the IB will need to be sent to RIC. See the FAQ on requesting an IB “How do I request access to Investigator's Brochure (IB)?” below.

Please note that if an IB is declined then the hyperlinks will not be available. If the CRS Leader, CRS Coordinator, Study Chairs, Co-chairs or the Vice Chairs selects the “decline” option when acknowledging the IB, the documents are not accessible. Once the CRS Leader, CRS Coordinator, Study Chairs, Co-chairs or Vice Chairs makes this selection, it cannot be changed. You will need to contact DAIDS RSC RIC at (RIC@tech-res.com) to request another IB. See FAQ “How do I request access to Investigator's Brochure (IB)?” below.

You will need to contact the DAIDS RSC RIC to request the IB. In your request, please include the name of the IB, the protocol it supports, your site number and the reason you need the IB (i.e., you accidently declined the acknowledgment). Please send this information to the RIC at (RIC@tech-res.com).

Send a request via e-mail to the RIC (RIC@tech-res.com). Include the following information:

• Name of the Investigator’s Brochure
• Protocol Number the IB supports
• Your site number and site name
• Name of the CRS Leader and CRS Coordinator

An email notification with access to the document will be sent within 5 business days of the request receipt. If you have not received the document within 8 business days of the request, contact the RIC via phone @ 301-897-1708 to confirm your request has been received and processed.

Note: Per DAIDS policies, only the CRS Leader, CRS Coordinator, Study Chairs, Co-chairs and Vice Chairs can receive the IB due to the confidential nature of the document.

DAIDS cannot dictate to the sites what information needs to be submitted to individual IRBs. Sites should follow local IRB procedures regarding safety information.

DAIDS has indicated that sites are only required to have on file the safety reports that have been distributed since their registration to the protocol. Sites are not required to have all of the reports which have been distributed since the protocol was initiated.

The PI is obtained directly from the drug company. As such, the RSC cannot comment on any changes in the document provided by the drug company. The newer PIs now have a “highlights of prescribing information” section at the beginning of the PI. Included in the highlights section is a listing of sections that have “recent major changes”. Please note that as of February 1, 2012 a Pilot program is in place to provide sites with changes made to updated PIs. Please see FAQs 15 and 16 for further information on this Pilot program.

DAIDS has indicated that the site should follow local IRB/EC policy in submitting the safety reports as specified in the cover memo. If the IRB requires that the reports be submitted within a different timeframe, the site should follow the requirements of their IRB.

An adverse event distributed as part of a Safety Memo is an event that has occurred in a drug company sponsored trial. If a site receives a question regarding an event that was distributed by DAIDS as a Safety Memo, contact the RSC Safety Information Center (RIC) with the question. RIC will forward the question to the relevant drug company. The site should receive a response directly from the drug company.

No. The new requirements only apply to new and recently approved prescription drugs. This includes those that were approved on or after the effective date of the Final Rule, drugs that have been approved in the 5 years prior to the effective date of the Final Rule, and older drugs for which there is a major change in the prescribing information (e.g., approval of a new use). Many older approved drug products are not required to meet the content and format revisions, though they may have to provide additional patient information. They can voluntarily revise their prescribing information. (Note: This information was taken directly from the FDA’s website. The Final Rule was published in January 2006 and became effective on June 30, 2006.) https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm084159.htm

The RIC distributes a monthly report via e-mail (in excel format) listing all of the safety information which has been distributed for a year (i.e., the monthly mailer sent in July will contain information from July 1 of the previous year through June 30) by the 10th of each month. This report can be sorted by protocol to compare documents that have been received with documents that have been distributed. If you are missing a report, contact the RIC (RIC@tech-res.com). If you have not received the monthly report by the 10th of the month, contact the RIC.

To enlarge and print parts of the document:

1. Open the PDF
2. On the toolbar, select “Tools”
3. Go to “select and zoom”
4. Go to “snapshot tool”
5. Highlight the limited area on the document you wish to print
6. Print preview: should say “selected graphic and fit to printable area”
7. Print

​The document was generated using the Adobe Acrobat 9 compare documents function, and shows the text from the updated PI Version with three types of updates noted.

Note: Formatting updates are not shown in the comparison document.

• Inserted text is underlined.
• Replaced text (text was deleted and text was added) is highlighted. Replacements also have a number associated with them that correlates with a comment on the comments list.
• Deleted text is displayed as strikethrough. The number correlates to a comment on the comments list.

For details on how to run your own document comparison, please refer to Adobe help links such as https://helpx.adobe.com/support/acrobat.html

A document will only be provided if a prior version of the PI was posted to the DAIDS RSC website.

For detail on the answer of this question, please refer to FAQ for Monthly Comprehensive Report

A potential problem could be the settings on your e-mail filters. Your e-mail filter must allow you to receive e-mail traffic from CRMSsupport@niaid.nih.gov. Check with your IT Department.