Personal Data Protection has become more stringent in India. In Part II, we discuss the consent requirements, rights and duties of the participants, and responsibilities of research sites, CROs, and sponsors.
#ResearchLaw#DataProtection#ClinicalResearch
https://t.co/QhhDQMfhLF
The Personal Data Protection laws in India. A new act came into effect in late Aug 2023. What do these new requirements mean for research stakeholders? In part I, we look at the scope, definitions, and implications of data breaches per the new law. https://t.co/VpflzsSegv
The WHO has developed a tool to assess the Ethics Oversight of research in human participants. Ethics committees/ review boards can use this tool to align their systems, processes, and procedures to a global benchmark. #IRB#GCP#EthicsReview
https://t.co/XRkAB05QUN
Sharing study results with study participants has been a neglected area in medical research. Is this a lost opportunity to engage the participants, community and public at large?
#research#clinicalresearch#clinicaltrialreporting
https://t.co/fO2hDUSO9V
Confidentiality and privacy of study participants are sacrosanct in research. However, what are a research teams responsibilities in research involving unlawful activities or events. Some thoughts on this topic. https://t.co/W7AcvtMmPX #researchethics
Our participants included pharmacy, biotech students, investigators, site staff, research professionals, ethics committee members, and medical professionals.
#trainingfeedback
WE ARE 5 YRS OLD!
We supported national/international studies in Infectious diseases, Pediatric diseases, Infertility, Ophthalmology and Orthopedics for pharmaceutical products, nutraceuticals, and medical devices.
#clinicalresearch
WE ARE FIVE YEARS OLD
We believe in sharing our experiences and learnings. Training is our passion. This drive extended beyond GCP into areas of organisational development, quality management, mentorship, and critical research skills. #researchtraining#GCP#researchethics
In the last 15 mnths, researchers, healthcare, & clinical trial professionals, have demonstrated the importance of their work. They have strived to find solutions to the pandemic in partnership with study participants who took on the risk & contributed to COVID studies. #ictd2021
Three important questions answered here- 1) How does vaccination help? 2) Will we need boosters because of new variants? 3) Why gatherings (even small indoor parties) should be avoided? #healthcare#covid19awareness#covid19insights https://t.co/el054CXjB2
A step forward in online reporting of Serious adverse events in clinical trials in India. How daunting will it be? How do we prepare to implement this change? What challenges do you foresee? #saeindia#clinicaltrials https://t.co/nIQM5kZ12V via @LinkedIn
2017 to 2021. A journey that has helped us share our expertise with people & organizations to further research & healthcare. We thank our >100 clients, CTQ collaborators, & employees for walking with us on this journey. We look forward to your blessings for many years to come.
Opthalmology examinations require in-clinic visits by patients. How can ophthalmology studies embrace technology to reduce the burden of travel for participants? #clinicaltrials#digitalhealth#clinicalresearch https://t.co/s41pEciKJe