News & Information
Sterling IRB Updates
1. Process Change - Receipt of Acknowledgments
2. SilverLink - 21 CFR 11 Compliant
3. Sterling IRB Receives Full AAHRPP Accreditation
4. New Program: Random Site Audits
5. Updated Policies: Cognitively Impaired Subjects
6. Reportable Events
Effective 08/01/10
Effective August 1, 2010 Sterling IRB will no longer mail hard copies of Acknowledgments of items such as IND Safety Reports,
Form FDA 1572s, CVs, Licenses, Investigator's Brochures, Financial Disclosures, and Notes to File that are not sent to the
full Board for review. Acknowledgments of these items will be provided on SilverLink or by email. Please note Acknowledgments
of items such as Protocol Deviations, Serious Adverse Events, and Unanticipated Problems that are not sent for full Board review
are currently only provided on SilverLink or by email.
04/02/10
We are pleased to announce that Sterling IRB's web portal, SilverLink, is in compliance with Title 21 Part 11 of the Code of Federal Regulations. SilverLink allows sponsors and investigators to easily submit and access important research documents electronically, streamlining the research process even further.
03/12/10
Sterling Institutional Review Board is pleased to announce that it has received full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Accreditation signals to sponsors and investigators that Sterling IRB provides comprehensive protections for research participants. Sponsors and investigators now have an industry-recognized assurance of Sterling’s commitment to exceed federal regulatory requirements and to continually improve quality and efficiency.
As the "gold seal," AAHRPP accreditation offers assurances to research participants, researchers, sponsors, government regulators, and the general public that a human research protection program is focused first and foremost on excellence not only in protecting research participants, but also in the advancement of more efficient and effective research. More information about AAHRPP accreditation is located at www.aahrpp.org and AAHRPP’s press release regarding Sterling’s accreditation is available at http://www.aahrpp.org/www.aspx?PageID=340.
Ted Green, president and CEO of Sterling Independent Services, Inc., states "We are pleased that Sterling IRB has received AAHRPP full accreditation. We hope that this distinction further demonstrates Sterling’s commitment to excellence."
01/26/10
See Chapter 4-D of the Investigator Handbook for details of Sterling IRB’s new program to audit investigative sites meeting select risk and/or enrollment criteria at random.
01/26/10
Please make note of changes in Sterling IRB’s policy pertaining to the review of studies that may involve cognitively impaired persons:
- See Chapter 9-D of the Investigator Handbook, noting Sterling IRB’s policy pertaining to obtaining assent (when possible) from persons unable to provide legally effective informed consent, including documentation of their assent to participate, and the added details regarding the continued verification of capacity to consent throughout the study.
- New Study Submission Application updated: revised question 22 (re ICD(s) submitted with protocol).
- Submission Application for the Investigator/Site updated: added questions 33 (re plan for determining capacity to consent/assent) and 38 (re process for continued verification of a subject’s capacity to consent).
- Registry Study Submission Application for the Investigator/Site updated: added questions 21 (re process for continued verification of a subject’s capacity to consent) and 28 (re plan fordetermining capacity to consent/assent).
01/26/10
Sterling IRB requires Principal Investigators (PI) to promptly report all events that may constitute unanticipated problems involving risk to subjects or others and new or updated safety information relating to the study or study product.
Unanticipated Problems Involving Risk to Subjects or Others are considered, in general, to include any incident, experience, or outcome that meets the following criteria:
- Unexpected: (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
- Related or possibly related: to participation in the research (possibly related means that there is a reasonable possibility that the incident, experience, or outcome may have been caused by the study product or procedures involved in the research); and
- Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
The following events/safety information should be reported to Sterling IRB within 10 business days.
- Serious Adverse Events
- Significant Protocol Deviations
- Prospective Protocol Exceptions
- Other Unanticipated Problems
- External SAE reports (e.g., IND Safety Reports)
- Complaints from research subjects (minor subject complaints that are adequately resolved by the research staff do not need to be reported)
- Reports, publications, or interim results or findings
- DMC or DSMB reports and recommendations
- Regulatory Agency Public Health Advisory
- New or updated study product information
- Revised Investigator Brochure
- Revised label / Package Insert
- Revised Device Manual
- Sponsor or regulatory agency recall / withdrawal / clinical hold
- Adverse sponsor or regulatory agency audit or enforcement action
Please see Chapter 7 – Reportable Events and Chapter 10 – Research Conflicts and Non-compliance in the Sterling IRB Investigator Handbook for additional information regarding reporting guidelines.
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