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FDA Announced Draft Guidance: Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank https://www.clinicalpathwaysresearch.com/blog/2018/10/29/sandra-sam-sather-speaking-at-mcc-summit-nov-14-15 monthly 0.5 2019-02-21 https://images.squarespace-cdn.com/content/v1/55343e1fe4b0c39656d4ba43/1540823962974-TS9XBM8W2GKVPM4E503S/MCC+SAM.PNG Blog - Sandra “SAM” Sather Speaking at MCC Summit Nov. 14-15 https://www.clinicalpathwaysresearch.com/blog/2018/10/24/scrs-grieves-the-passing-of-president-and-founder-christine-pierre monthly 0.5 2019-02-21 https://images.squarespace-cdn.com/content/v1/55343e1fe4b0c39656d4ba43/1540408172032-B9A3UDD2KV8I3FI4Y3WP/image-asset.jpeg Blog - SCRS Grieves the Passing of President and Founder Christine Pierre https://www.clinicalpathwaysresearch.com/blog/2018/10/23/fda-announced-draft-guidance-the-special-510k-program monthly 0.5 2019-02-21 https://images.squarespace-cdn.com/content/v1/55343e1fe4b0c39656d4ba43/1540303554500-JOBNWCWV51UIN1QZ3KB2/image-asset.png Blog - FDA Announced Draft Guidance: The Special 510(k) Program https://www.clinicalpathwaysresearch.com/blog/2018/10/18/fda-releases-guidance-on-benefit-risk-factors-in-substantial-equivalence-in-510k-submissions monthly 0.5 2019-02-21 https://images.squarespace-cdn.com/content/v1/55343e1fe4b0c39656d4ba43/1539870578298-0I7Z86BYAVQXPAZV4YSO/image-asset.jpeg Blog - FDA Releases Guidance on Benefit-Risk Factors in Substantial Equivalence in 510(k) Submissions https://www.clinicalpathwaysresearch.com/blog/2018/10/15/come-experience-the-first-ever-metrics-champion-consortium-summit-nov-14-15 monthly 0.5 2019-02-21 https://images.squarespace-cdn.com/content/v1/55343e1fe4b0c39656d4ba43/1540823894854-KTDXY2OD40JJH8ICS2QB/MCC.png Blog - Come Experience the First Ever Metrics Champion Consortium Summit: Nov. 14-15 https://www.clinicalpathwaysresearch.com/blog/2018/10/12/very-helpful-resource-good-clinical-practice-a-question-amp-answer-reference-guide-2018 monthly 0.5 2019-02-21 https://images.squarespace-cdn.com/content/v1/55343e1fe4b0c39656d4ba43/1539376316916-WFXIJSWZJH3HS30E5D84/image-asset.jpeg Blog - Very Helpful Resource: Good Clinical Practice: A Question & Answer Reference Guide 2018 https://www.clinicalpathwaysresearch.com/blog/2018/10/10/cro-oversight-post-ich-gcp-e6-r2-addendum-october-24-2018-course monthly 0.5 2019-02-21 https://images.squarespace-cdn.com/content/v1/55343e1fe4b0c39656d4ba43/1539207496389-9RSTLVVPPLM86W3RT0CH/image-asset.jpeg Blog - CRO Oversight Post ICH GCP E6 (R2) Addendum: October 24, 2018 Course https://www.clinicalpathwaysresearch.com/blog/2018/10/9/more-common-myths-about-econsent monthly 0.5 2019-02-21 https://images.squarespace-cdn.com/content/v1/55343e1fe4b0c39656d4ba43/1539093026718-Y74IMD2NWY6HL074NOZE/eConsent.png Blog - More Common Myths about eConsent https://www.clinicalpathwaysresearch.com/blog/2018/10/5/new-guidance-for-irb-written-procedures-released-impact-to-sponsor-and-investigators monthly 0.5 2019-02-21 https://images.squarespace-cdn.com/content/v1/55343e1fe4b0c39656d4ba43/1538754948452-OSVGG721EG16C2Q264HW/IRB+Written+Procedures.jpg Blog - New Guidance for IRB Written Procedures Released: Impact to Sponsor and Investigators https://www.clinicalpathwaysresearch.com/blog/2018/10/3/certified-copies-and-alcoa-c-essentials-post-ich-gcp-e6-r2-addendum-october-9-2018-course monthly 0.5 2019-02-21 https://images.squarespace-cdn.com/content/v1/55343e1fe4b0c39656d4ba43/1538603493467-MQF7I1SXJD4XEBF8L5L4/ICH.jpg Blog - Certified Copies and ALCOA-C: Essentials Post ICH GCP E6 R2 Addendum: October 9, 2018 Course https://www.clinicalpathwaysresearch.com/blog/2018/8/27/sandra-sam-sather-speaking-at-september-2018-acrp-ny-metro-chapter-webinar-c6txl-4ln43 monthly 0.5 2018-09-12 https://images.squarespace-cdn.com/content/v1/55343e1fe4b0c39656d4ba43/1535403591821-IU7B2CJHCJDXD8N4AT08/Capture.PNG Blog - Sandra SAM Sather Speaking at ACRP September 17, 2018 In-Person Event Sandra SAM Sather, MS, BSN, CCRC, CCRA Vice President of Clinical Pathways, LLC https://www.clinicalpathwaysresearch.com/blog/2018/8/27/sandra-sam-sather-speaking-at-september-2018-acrp-ny-metro-chapter-webinar-c6txl monthly 0.5 2018-09-12 https://images.squarespace-cdn.com/content/v1/55343e1fe4b0c39656d4ba43/1535403591821-IU7B2CJHCJDXD8N4AT08/Capture.PNG Blog - SAM Sather Speaking at September 2018 ACRP NY Metro Chapter Webinar Sandra SAM Sather, MS, BSN, CCRC, CCRA Vice President of Clinical Pathways, LLC https://www.clinicalpathwaysresearch.com/blog/2018/7/24/fda-final-guidance-for-electronic-health-record-data-released monthly 0.5 2018-07-24 https://images.squarespace-cdn.com/content/v1/55343e1fe4b0c39656d4ba43/1532470562089-XYD1OC6JVYGOX0IXDN78/PIC.png Blog - FDA FINAL Guidance for Electronic Health Record Data Released! https://www.clinicalpathwaysresearch.com/blog/2018/7/17/cro-oversight-post-ich-gcp-e6-r2-addendum-july-18-2018-course monthly 0.5 2018-07-17 https://images.squarespace-cdn.com/content/v1/55343e1fe4b0c39656d4ba43/1531832213136-983Z363B4UAF3REAVUUR/j.png Blog - CRO Oversight Post ICH GCP E6 (R2) Addendum: July 18, 2018 Course https://www.clinicalpathwaysresearch.com/blog/2018/7/13/remote-access-to-phi monthly 0.5 2018-07-13 https://images.squarespace-cdn.com/content/v1/55343e1fe4b0c39656d4ba43/1531516272058-P668GQ45ERRNIK05OLVU/Image.jpg Blog - 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Pediatric Clinical Trials: Special Considerations and Requirements - June 4th, 2018 Course https://www.clinicalpathwaysresearch.com/blog/2018/5/26/an-irb-perspective-on-improving-informed-consent-published-in-clinical-researcher monthly 0.5 2018-05-26 https://images.squarespace-cdn.com/content/v1/55343e1fe4b0c39656d4ba43/1527349674838-8ZO3NLLA9AJ8UVOV7BFT/ACRP+logo+image.png Blog - “An IRB Perspective on Improving Informed Consent” Published in Clinical Researcher https://www.clinicalpathwaysresearch.com/blog/2018/5/25/eus-general-data-protection-regulation-gdpr-effective-on-may-25-2018 monthly 0.5 2018-05-25 https://images.squarespace-cdn.com/content/v1/55343e1fe4b0c39656d4ba43/1527260769769-QEPK86CWSI7C5R3T8IGW/gdpr.jpg Blog - EU’s General Data Protection Regulation (GDPR) Effective on May 25, 2018 What is the GDPR? The European Union’s (EU) General Data Protection Regulation (GDPR) goes into effect on May 25, 2018. The purpose of the GDPR is to protect the privacy and security of personal data and to strengthen the accountability to those using personal data. What does this mean for clinical trials? Personal data collected on subjects within the member states of the EU must comply with the GDPR, even if the study is not based in the EU. Interestingly, this would also include data collection on subjects who travel to the EU and are not residents. Data collection on EU residents who are outside the EU at the time of data collection are not covered under GDPR. To learn more about how GDPR affects study subjects, click here. Thanks to Advarra for this great summary! -The Clinical Pathways Team Enjoy this blog? 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