Translating Research into Highest Quality Patient Care

Clinical Research Coordinator Society (CRCS) Forums


Clinical Research Coordinator Society (CRCS) Forums

 

The CRCS is a community comprising clinical research coordinators across various public healthcare institutions in Singapore. CRCS seeks to address the training and educational needs for clinical research coordinators involved in supporting the conduct of research studies.

As part of these educational efforts, CRCS forums are held several times a year, as a platform for information sharing, exchange of ideas and networking across the community. CRCS also collaborates with the Clinical Research Professional (CRP) community in Singapore in organising these educational initiatives.
 

 

 

Presentation Materials from Past CRCS Forums

 

Presentation materials (with speakers’ agreement) from past CRCS forums are available for download below:

 

2021

CRCS-CRP Forum
2 Jan 2022

Looking Back at 2021
Ms. Sumitra Sachidanandan

Regulatory Consultant - GCP Unit
Innovation Office & Clinical Trials Branch
Medical Products Pre-market Cluster
Health Products Regulation Group
Health Sciences Authority Singapore

 

2021

SCRI-NHG CRCS forum -Cum- CRC appreciation day

Managing the impact of clinical trials during the COVID-19 pandemic
Ms. Sumitra Sachidanandan
 
Regulatory Consultant
Innovation Office & Clinical Trials Branch
Health Products Regulation Group
Health Sciences Authority Singapore

 

2019

CRCS-CRP Forum

3 Dec 2019

 

Looking back at 2019
Ms. Sumitra Sachidanandan
Regulatory Consultant – GCP Unit, Innovation Office & Clinical Trials Branch, Medicinal Products Pre-market Cluster, Health Products Regulation Group, Health Sciences Authority


Requirement of Appropriate Consent for Conduct of Human Biomedical Research and Handling of Human Tissue
Dr. May Thu MA
Senior Manager, Biomedical Research Regulation Branch, Regulatory Compliance & Enforcement Division, Health Regulation Group, Ministry of Health

 

 

 

 

2018


CRCS-CRP Forum

07 Dec 2018
 

  • Looking back at 2018 (Slides Pending)

 

  • Looking back at 2018 Ms Sumitra Sachidanandan, Regulatory Consultants - GCP Unit, Innovation Office & Clinical Trials Branch, Medicinal Products Pre-market Cluster, Health Products Regulation Group, HSA

 

 

14 Sep 2018
 

   

 

 

 

 

2017

 
CRCS-CRP Forum

1 Dec 2017

Implications for Investigator Initiated Trials - Risk Based Approaches in Managing Clinical Trials - Ms Lisa Marie Saldanha, IQVIA

 

 

 

The presentation shared by HSA can be accessed here:
http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Clinical_Trials/Industry_Communication.html


The following topics can be accessed from the ‘Presentations’ section of HSA website:

Looking Back at the Changes in Clinical Trials and CRM Regulations
IMDA Briefing to HSA Clinical Trials Stakeholders


The following topic can be accessed from the ‘Presentations – Common GCP Inspection Findings’ section of the website/
Common GCP Inspection Findings in 2017

 


CRCS-CRP Forum

25 Aug 2017

 

 

 

 

2016

 
CRCS-CRP Forum

9 Dec 2016


 

 

  • Risk-based monitoring: After Years of talking about it, where are we now?  | Slides
     
  • Human Biomedical Research Act: Scope and Regulatory Framework  | Slides

 

CRCS-CRP Forum

26 Aug 2016

 

  • PDPA Updates: Management and Protection of Patients’ Data (Mr Benjamin Cheong, Rajah & Tann Singapore LLP) | Slides  
     
  • Considerations for Using Electronic Medical Records (EMR) in Clinical Trials (Mr Alex Goh, GlaxoSmithKline Pharmaceuticals) | Slides  
     
  • Management of Electronic Trial Master Files and Essential Documents in Pharma and CROs (Ms Jingyi Lin, PAREXEL) | Slides
     
  • Using Electronic Patient-Reported Outcomes (ePRO) in Clinical Trials: Lessons Learnt (Ms Chong Pei-Fen, Quintiles) | Slides

 

 

 

 

2015

 

CRCS-CRP Forum

3 Dec 2015

 

  • Updates from the GCP Inspection Team, Ms Sumitra Sachidanandan, Health Sciences Authority | Slides (from HSA)

 

 

CRCS-CRP Forum

28 Aug 2015

 

  • Ethically and scientifically sound: Actual reviews of applications involving vulnerable populations (Dr Patricia Yap, IMH) | Slides

 

  • Research in Children: Challenges (Prof Quak Seng Hock, NUH) | Slides

 

  • The Process of Obtaining Informed Consent in Vulnerable Population (Prof Swapna Verma, IMH) | Slides

 

 

 

 

2014

 

CRCS-CRP Forum

12 Dec 2014

 

 

 

 

  • Common GCP Inspection Findings for 2014 (Ms Sumitra Sachidanandan, HSA) | Slides

 

  • Serious Breaches (Ms Poh Cuiqin, HSA) – The Guidance on Serious Breaches will be released by HSA at a later date.

 

 

 

 

 

 

CRCS Forum

25 July 2014

 

 

  • Conducting Monitoring Visit for Investigator-Initiated Studies (Mr Xia Yu, SCRI)  | Slides 

 

 

  • Quality Control for Phase I Trials – Site Perspectives (Ms Yew Lay Hwa, CGH) | Slides 

 

  • Impact of Privacy Laws in Clinical Trials (Ms Rebecca Chew, Rajah & Tann LLP) | Slides