| 1. |
How do I get on the list to receive safety information such as Safety Reports, Investigator's Brochures (IB) and Package Insert (PI) notices? |
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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 and CTU/CRS Coordinators only, as identified in Master Contact. 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:
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| 2. |
Is there any way to separate protocols in development from active protocols for safety report distribution? |
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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). |
| 3. |
Can I receive an Investigator’s Brochure (IB) electronically via e-mail? |
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Due to the confidential nature of the IB, it cannot be provided electronically as an e-mail attachment. Per DAIDS procedures, IBs are sent as a PDF on a CD-ROM. |
| 4. |
Do I need to submit this safety information to my Institutional Review Board (IRB)? |
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DAIDS cannot dictate to the sites what information needs to be submitted to individual IRBs. Sites should follow local IRB procedures regarding safety information. |
| 5. |
How do I get safety information that was distributed prior to my site registration date? |
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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. |
| 6. |
What changes can I look for once a Package Insert (PI) update has been posted on the RSC website? |
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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. |
| 7. |
In the cover memo for Safety Memos, it states that the information must be sent to the Institutional Review Board (IRB) within 30 days. Our IRB policy has a different timeframe. Whose instructions should we follow? |
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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. |
| 8. |
How do I handle Institutional Review Board (IRB) questions regarding an adverse event distributed in a Safety Memo? |
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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. |
| 9. |
For Package Inserts (PI), will all prescribing information for human drug and biological products be required to conform with the new content and format requirements? |
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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.)
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules
/ucm084244.htm |
| 10. |
How do I check to confirm that I have received all of the safety information? |
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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 recieved the monthly report by the 10th of the month, contact the RIC. |
| 11. |
Who should sign the fax back cover sheet confirming receipt of the Investigator’s Brochure (IB)? |
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Due to the confidential nature of the document, the fax back confirmation sheet should be signed by the Site Leader or Principal Investigator to whom it is sent. If that person is unavailable, someone who is authorized to sign for the Site Leader or Principal investigator can sign for that person. |
| 12. |
What is the potential issue if I have the role of Site Leader, Site Coordinator, CTU Leader, CTU Coordinator or Investigator of Record but I do not receive the safety mailer even though the RSC Safety Information Center (RIC) has confirmed that the document has been sent to my e-mail address? |
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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 DAIDS-ESSupport@niaid.nih.gov. Check with your IT Department. |
| 13. |
What can I do if a PDF document is difficult to read when it is printed? |
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To enlarge and print parts of the document:
a. Open the PDF
b. On the toolbar, select “Tools”
c. Go to “select and zoom”
d. Go to “snapshot tool”
e. Highlight the limited area on the document you wish to print
f. Print preview: should say “selected graphic and fit to printable area”
g. Print
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| 14. |
How do I request an Investigator's Brochure (IB)? |
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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 Site Leader/Principal Investigator
- Mailing address
A CD-ROM containing a PDF of the document will be sent via Federal Express (2 day) 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 Site Leader/Principal Investigator can receive the IB due to the confidential nature of the document.
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| 15. |
How do I interpret the comparison document associated with a Package Insert (PI)? |
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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.
a. Inserted text is underlined.
b. 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.
c. Deleted text is indicated with a  . 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 http://help.adobe.com/en_US/Acrobat/9.0/Professional/WS09D04D24-A9FA-416b-9FBC-6188AC2160FF.w.html |
| 16. |
Why did I not receive a document which shows the modifications made in the updated PI? |
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A document will only be provided if a prior version of the PI was posted to the DAIDS RSC website. |
| 17. |
How do I Use the Monthly Comprehensive Safety Distribution Report? |
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For detail on the answer of this question, please click on the link: FAQ for Monthly Comprehensive Report.doc. |