SACRA South Africa’s Post

✨ Study Delegation of Responsibility log. This is an essential study document that is developed by the study PI that shows how he or she has delegated some of the trial activities. This document should have the study roles indicated, the names of the staff who is to conduct the role/s, start date of the staff to implement the role/s delegated, the end date, section for signature of the study staff and study PI. DoR log should be well kept in the investigator site file and also a copy in the IMF at the sponsor’s office. It should be updated in case new study staff is recruited to conduct trial activities. The principal investigator should ensure the newly recruited staff are qualified and well trained in trial related activities before they are added on the DoR log.  The principal investigator can delegate certain tasks, they cannot delegate overall responsibility 😊 . He or she is responsible for supervising any individual or party that they delegate study tasks to at the trial site.

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Looking for sites for your commercial study or trial? How does 3.5 times higher patient recruitment sound? Register your study for our Associate Principal Investigator (PI) Scheme 👇 This initiative provides in-work training opportunities for healthcare professionals seeking to gain practical experience in research delivery under the mentorship of existing Principal Investigators. If matched to one or more Associate PIs, your study will receive increased support at those sites. Read a peer-reviewed article which sets out why this scheme is a win-win opportunity for sponsors and trainee PIs: https://lnkd.in/gFmPsPUD

📅UPCOMING INVESTIGATOR & SITE STAFF COURSE: The planning, preparing, and organising of clinical trials have become a highly complex task that includes important issues such as: the need to protect participants generate reliable data, perform trials efficiently within short timelines, fulfil quality requirements according to current legislation and inspection requirements, utilisation of new technology and conduct clinical trials within budget to ensure sustainable business. 👉 Secure your spot, registrations now open! For more information regarding the programme, topics, presenters and fees visit our website: https://lnkd.in/d9RhquT9 Sorika van Niekerk Adriaan Kruger Leonard Neil L. Rob van den Bergh Charlotte Botha James Farhaad Shaik Reinard Mc Pherson, MBChB, CPI Azwidihwi Takalani Benjamin du Toit - Enslin Sonnika van Vuuren Ida Ndlovu Tevan Naidoo #INVESTIGATORS #COURSE #GCP #STAYINFORMED #EDUCATEYOURTEAM #CLINICALTRAILS #RESEARCHSITES #PRINCIPLEINVESTIGATORS #SITESTAFF #REGISTERNOW

Advancing Expertise: Clinixir CRA Academy In the third phase of the Clinixir CRA Academy, participants reach a significant milestone in their journey towards becoming proficient #ClinicalResearch #Associates (CRAs). Armed with a certified understanding of #GoodClinicalPractice (GCP) and a comprehensive grasp of ethical principles governing research involving human subjects, participants are well-prepared to navigate the complexities of the clinical research domain. Clinixir empowers participants with the expertise to execute their roles with precision, maintaining the highest standards of integrity and #compliance throughout the research process. Equipped with this knowledge, our participants are poised to become invaluable assets in safeguarding the integrity and credibility of #clinicaltrials As we continue this enlightening journey, participants are primed to apply their acquired expertise in real-world scenarios, ensuring the ethical execution and reliability of clinical research.

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Many people interested in clinical research find the duties of a clinical research associate (CRA) attractive but may not realize that applicants often need prior experience as a clinical research coordinator (CRC) or clinical trial assistant (CTA). Anthony Chew’s forthcoming article in ACRP’s Clinical Researcher journal reveals that more than two-thirds of surveyed CRAs held CRC or CTA positions first, highlighting the value of these roles as stepping stones in the clinical research field. Read more in a recent blog preview > https://bit.ly/4bh4ie8 Learn more about the ACRP CCRA Certification > https://bit.ly/4bhURv0 #ACRPCertification #CCRA #ClinicalResearchAssociate #CRA #ClinicalResearch #ClinicalTrials

Pre-Study Visit: This has different names depending on the company. This may also be known as; Site Selection Visit (SSV), Site Qualification Visit (SQV) and Site Evaluation Visit (SEV).  CRA’s main purpose for a Pre-Study Visit: 👨💻 To ensure the site has all necessary personnel, infrastructures and equipment. 👨💻 Study site has access to patient population under study before being selected to participate in the trial. 👨💻 To avoid study start-up delays and sites not meeting their target enrollment.  CRAs need to select optimal sites for the trial.