TASK Research Academy

Did you know? TASK Research Academy has launched a podcast called TRA TALKS! 🎙️   Join our Director, Karen Cloete, for quick, insightful episodes that break down the latest updates to ICH GCP E6 (R3) —all in bite-sized, easy-to-digest chunks.   In our latest episode, we delve into ICH GCP E6 (R3) Part 5: Data Governance, exploring the critical aspects to ensure data integrity in clinical research.   🎧 Listen now and follow us here: https://lnkd.in/gfvdf_ic   #TASKResearchAcademy #ClinicalTrials #Podcast #DataGovernance

ICH GCP E6(R3) – DATA GOVERNANCE – FOR SPONSORS AND INVESTIGATOR STAFF (Part 2) Data Governance is an entirely new section in the ICH GCP R3 guideline that is relevant to the sponsor and the investigator team. With the extensive use of computerised systems in clinical trials, which the previous guideline (R2) partially addressed, this new section provides a higher level of guidance that reflects more detailed guidance published in this area by Regulatory Authorities such as the EMA, FDA, and the MHRA’s Data Integrity Guidance. As we see right through the update of R3, this section again focuses on the quality of the information we capture in the trial sufficient to provide reliable results and that all processes and systems in the data life cycle should be fit for purpose and implemented proportionately to the risk. Sponsors, CRAs, Data Managers, Investigators and teams needs to shift their focus on collecting, capturing, reviewing, managing and analysing important data (significant data) – those data that, if not recorded, might have an impact on participant safety and data integrity. To maintain compliance and upskill you and your staff with an in-depth understanding of all these changes, TRA has developed online training for ICH GCP E6(R3). Register here: https://lnkd.in/dkS4bvdK If you missed our webinar: ICH GCP E6(R3) WHAT NOW? on 13 February, don't stress! You can watch the recording here where TRA discussed the impact of the new updates: https://lnkd.in/dQ4r7XpB

ICH GCP E6(R3) – DATA GOVERNANCE – FOR SPONSORS AND INVESTIGATOR STAFF (Part 1) Data Governance is an entirely new section in the ICH GCP R3 guideline that is relevant to the sponsor and the investigator team. With the extensive use of computerised systems in clinical trials, which the previous guideline (R2) partially addressed, this new section provides a higher level of guidance that reflects more detailed guidance published in this area by Regulatory Authorities such as the EMA, FDA, and the MHRA’s Data Integrity Guidance. As we see right through the update of R3, this section again focuses on the quality of the information we capture in the trial sufficient to provide reliable results and that all processes and systems in the data life cycle should be fit for purpose and implemented proportionately to the risk. Sponsors, CRAs, Data Managers, Investigators and teams needs to shift their focus on collecting, capturing, reviewing, managing and analysing important data (significant data) – those data that, if not recorded, might have an impact on participant safety and data integrity. To maintain compliance and upskill you and your staff with an in-depth understanding of all these changes, TRA has developed online training for ICH GCP E6(R3). Register here: https://lnkd.in/dkS4bvdK If you missed our webinar: ICH GCP E6(R3) WHAT NOW? on 13 February, don't stress! You can watch the recording here where TRA discussed the impact of the new updates: https://lnkd.in/dQ4r7XpB

Attention CRAs and Central Monitors. The updated ICH GCP E6 R3 guideline also impacts you. Read below some of the changes. To ensure you are on top of all the changes to all sections of the new guidelines register for TASK Research Academy 's course 👇 #staycompliant

ICH GCP E6(R3) FOR CENTRAL AND SITE MONITORS (CRAs) Quality Assurance (QA) and Quality Control (QC) forms part of Sponsor Responsibilities. ICH GCP E6(R3) discusses this responsibility under a new section, "Sponsor Oversight." Monitoring, as part of the QA and QC section, has undergone extensive revision and reorganisation. A new section on Investigator Site Monitoring was added, and R3 now acknowledges remote monitoring and describes centralised monitoring as an important component of monitoring activities that are part of a risk-based approach. The guideline no longer states that “in general there is a need for site monitoring,” which is a significant change. ICH GCP E6(R3) emphasises that monitoring activities cannot be performed by those involved in the clinical conduct of the trial and that every site should have an assigned independent monitor as their point of contact. To maintain compliance and upskill you and your staff with an in-depth understanding of all these changes, TRA has developed online training for ICH GCP E6(R3). Register here: https://lnkd.in/dkS4bvdK If you missed our webinar: ICH GCP E6(R3) WHAT NOW? on 13 February, don't stress! You can watch the recording here where TRA discussed the impact of the new updates: https://lnkd.in/dQ4r7XpB

ICH GCP E6(R3) - FOR INVESTIGATORS, SITES AND PHARMACISTS (Part 2) Extensive changes have been made to the Investigator section of ICH GCP E6(R3), with significant deletions, promising additions, and some text restructuring, especially regarding the selection of service providers for trial-related activities (or "vendors" as we know them). There is a shift in focus to explain only important deviations; an option to now also allow other qualified healthcare professionals to be involved in the medical care of trial participants; and numerous and significant changes made in the investigator section relating to informed consent of trial participants, with a new section explaining Investigator responsibilities on withdrawal. Substantial changes and additions relating to records/data/computerised systems should also be considered. The section on IP accountability was updated to accommodate decentralised trials and authorised medicinal products used in clinical trials. To maintain compliance and upskill you and your staff with an in-depth understanding of all these changes, TRA has developed online training for ICH GCP E6(R3). Register here: https://lnkd.in/dkS4bvdK If you missed our webinar: ICH GCP E6(R3) WHAT NOW? on 13 February, don't stress! You can watch the recording here where TRA discussed the impact of the new updates: https://lnkd.in/dQ4r7XpB

ICH GCP E6(R3) - FOR INVESTIGATORS, SITES AND PHARMACISTS (Part 1) Extensive changes have been made to the Investigator section of ICH GCP E6(R3), with significant deletions, promising additions, and some text restructuring, especially regarding the selection of service providers for trial-related activities (or "vendors" as we know them). There is a shift in focus to explain only important deviations; an option to now also allow other qualified healthcare professionals to be involved in the medical care of trial participants; and numerous and significant changes made in the investigator section relating to informed consent of trial participants, with a new section explaining Investigator responsibilities on withdrawal. Substantial changes and additions relating to records/data/computerised systems should also be considered. The section on IP accountability was updated to accommodate decentralised trials and authorised medicinal products used in clinical trials. To maintain compliance and upskill you and your staff with an in-depth understanding of all these changes, TRA has developed online training for ICH GCP E6(R3). Register here: https://lnkd.in/dkS4bvdK If you missed our webinar: ICH GCP E6(R3) WHAT NOW? on 13 February, don't stress! You can watch the recording here where TRA discussed the impact of the new updates. https://lnkd.in/dQ4r7XpB

ICH GCP E6(R3) FOR SPONSORS AND SERVICE PROVIDERS (PART 2) The Sponsor section in ICH GCP E6(R3) had substantial changes and reorganisation. It’s all about designing quality protocols and systems with input from a wide range of stakeholders and clinical research professionals, ensuring your protocol and systems are fit for purpose - eliminating complexities that overburden the sites and participants – implementing a risk-proportionate approach and shifting the focus to identifying and managing important data that will have a significant impact on data credibility and/or participant safety. R3 is introducing the term "service providers", of which the CRO is now an example – acknowledging the increased use of small organisations providing specific services/trial activities to sponsors. New sections have shed light on Qualifications and Training for Sponsor Staff, Agreements, Sponsor Oversight, Statistical Programming, and Clinical Study reports, with significant updates to the section Data and Records. To maintain compliance and upskill you and your staff with an in-depth understanding of all these changes, TRA has developed online training for ICH GCP E6(R3). Register here: https://lnkd.in/dkS4bvdK You can also explore the enhanced role of sponsors in ICH GCP E6(R3) by listening to the second episode of TRA Talks with Task Research Academy Founder, Karen Cloete: https://lnkd.in/da72QGkK

ICH GCP E6(R3) FOR SPONSORS AND SERVICE PROVIDERS (PART 1) The Sponsor section in ICH GCP E6(R3) had substantial changes and reorganisation. It’s all about designing quality protocols and systems with input from a wide range of stakeholders and clinical research professionals, ensuring your protocol and systems are fit for purpose - eliminating complexities that overburden the sites and participants – implementing a risk-proportionate approach and shifting the focus to identifying and managing important data that will have a significant impact on data credibility and/or participant safety. R3 is introducing the term "service providers", of which the CRO is now an example – acknowledging the increased use of small organisations providing specific services/trial activities to sponsors. New sections have shed light on Qualifications and Training for Sponsor Staff, Agreements, Sponsor Oversight, Statistical Programming, and Clinical Study reports, with significant updates to the section Data and Records. To maintain compliance and upskill you and your staff with an in-depth understanding of all these changes, TRA has developed online training for ICH GCP E6(R3). Register here: https://lnkd.in/dkS4bvdK You can also explore the enhanced role of sponsors in ICH GCP E6(R3) by listening to the second episode of TRA Talks with Task Research Academy Founder, Karen Cloete: https://lnkd.in/da72QGkK

ICH GCP E6(R3) ON ESSENTIAL RECORDS ICH GCP E6(R2) referred to Essential Documents, a group of clinical trial documents that are created, collected, and filed before, during, and after a trial. These documents tell the story of the trial from beginning to end and are also audited/inspected and archived. In the past, these were mostly hard copies filed in multiple binders at the site and the sponsor. R3 now refers to them as Essential Records – another welcoming update supporting the broadening of the information required to assess the trial conduct to also include data. There are many more exciting changes to this section explained below. To get trained on all the updates and stay compliant register and enroll in TRA's course: Updates - ICH GCP E6(R3): https://lnkd.in/dkS4bvdK To discuss these changes and the impact on you and your organisation remember to: 1. Register for our FREE Webinar today, 13 February at 16h00 SAST: ICH GCP E6(R3) WHAT NOW? here: https://lnkd.in/dpVr7Nw5 2. Listen to the first episode of TRA Talks with Task Research Academy Founder, Karen Cloete: https://lnkd.in/g4iY-uPV