Translating Research into Highest Quality Patient Care

Chicken Soup for the Busy Coordinator


 

The Clinical Research Coordinator Society (CRCS) is aware that our multi-tasking coordinators often have to deal with ambiguous problems and situations. With this in mind, the Society launched the regular Chicken Soup emails in January 2008. These emails serve as bite-size educational resources for Clinical Research Coordinators.

The monthly Chicken Soup emails are easy to read and contain essential information and practical knowledge that can be applied at work. We hope that the Chicken Soup will indeed be a nourishing resource for you!

Do send us your suggestions on how to further improve the Chicken Soup service via researchcoord@nhg.com.sg with the “Chicken Soup for the Busy Coordinator” as the subject header.

Yours Sincerely
Clinical Research Coordinator Society (CRCS)
 

 

 

The Chicken Soup series for the Busy Coordinator

 

Disclaimer: Past articles may contain best practices or SOPs that are superseded. For NHG and partner institutions, we encourage you to refer to our website or the latest NHG PCR SOPs (available via NHG Intranet access or Partner Institution’s CRU/Research office).  Always refer to your own institution’s latest policy/ SOPs/ guidance documents/ templates.


 

Current Issue of Chicken Soup:

(Aug 22) Subject Management During Covid-19 - The use of e-Informed Consent 

 
Click on the Topics below to see the related articles.
  
(1) Biological Samples
(2) Data Collection & Source Documentation   
(3) Database (No related articles yet.)   
(4) DSRB Documentation   
(5) Informed Consent    
(6) Investigational Product Accountability   
(7) Investigator File and Overall Study Documentation   
(8) Pre-Study Activities   
(9) Regulatory Documentation   
(10) Research Policy, Guidelines & SOP Updates   
(11) Study Conduct   
(12) Study Team & Responsibilities   
(13) Subject Recruitment Procedures   
(14) Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSO)                       
(15) Non-Compliance
(16) Others

 

 

(1) Biological Samples

(Apr 21) Biological Specimen Management


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(2) Data Collection & Source Documentation   

 

(Jul 22) Research Data Management (Data Collection, Storage and Transfer)

(Jan 21) Study Data Collection and Database Maintenance

(Sep 20) Remote Source Document Verification (SDV) Requirements

(Jul 20) Ensuring Data Integrity With Principles Of Good Documentation

(May 20) Extraction Of Data For Use In Research Study

(Sept 19) How should research data be shared?

(Dec 18) How should research data be managed & stored?

(Nov 17) Transferring of Essential Documents (containing Subjects’ Identifiable Data) to an Overseas External Collaborator

(Oct 17) The Management and Storage of Research data

(Jul 17) Source Documentation

(Jun 17) Research Involving Non-English Speaking Subjects

(Oct 16) NHG RQM Common Study Review Finding: Data Collection & Source Documentation
   

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(3) Database


No related articles yet.


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(4) DSRB Documentation   

 

(Jan 22) Safety Event Reporting Guidelines to DSRB

(Aug 20) Study Submission & Interaction with DSRB. How to Reduce The Number of Queries?

(Aug 19) Death & Safety Event Reporting Requirements to DSRB

(Jun 19) What constitute a Minor or Major Protocol Amendment according to the NHG DSRB

(May 18) Study Amendments – Getting approvals and ensuring updated study documents are used

(Feb 18) How to determine if a Study falls under the Human Biomedical Research purview

(Aug 16) Tips on how a CRC can help ensure that protocol and ICF amendments are implemented after DSRB approval


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(5) Informed Consent

 

(Apr 2022) Changes to Assent requirements and Documentation - How does it impact your study? 

(Feb 22) Informed Consent Process During Covid-19 Period

(Oct 21) When is Re-consenting of Research Subjects Needed?

(Aug 21) Impartial Witness & Witness In Informed Consent-Taking For HBR Studies

(Dec 20) Pointers for Electronic Consent (e-Consent) 

(Nov 20) Informed Consent: When is an Impartial Witness Needed?

(Nov 19) How Should Consent Be Obtained From Subjects Lacking Mental Capacity?

(May 19) Witness requirements for Informed Consent process

(Oct 18) Obtaining Consent for Adults lacking mental capacity in Human Biomedical Research

(Jul 18) Re-consenting for HBR studies extending past 31 October 2018 involving the use of individually identifiable data/ materials

(Apr 18) Processes for Consenting A Subject Into A Clinical Trial In An Emergency Situation

(Sep 17) How should Consent be obtained for Subjects who are unable to read?


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(6) Investigational Product Accountability

 

(Nov 21) Common Findings related to Investigational Product (IP) Management


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(7) Investigator File and Overall Study Documentation

 

(May 21) How to Prepare for a Study Review or Audit?

(Feb 21) Investigator Site File (ISF) Management

(Feb 20) How to Ensure Consistency of Study Documents Throughout the Duration of the Research

(Apr 19) Essential Documents - Setting Up and Maintaining the Investigator File

(Mar'16) Declaration, Submission & Filing of the Financial Conflict of Interest Declaration Form

(Jan 16) How Research Misconduct Impacts the Principal Investigator, the Research Team and the Study


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(8) Pre-Study Activities

 

(Sep 21) How to conduct and document E-SIV 

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(9) Regulatory Documentation

 

(May 2022) How to Handle Leftover Tissues for Future Unapproved Research and Legacy Human Biological Material (LHBM)

(Dec 21) When and How to Register for a Standing Database

(Jan 20) How to Set Up a Tissue Bank?

(Jul 19) Clinical Research Material (CRM) notification for Clinical Research involving Medical Devices

HSA Regulatory overview of clinical trials


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(10) Research Policy, Guidelines & SOP Updates

 

(Mar 22) Responsible Conduct of Research (RCR) - Research Misconduct

(Mar 21) Mentorship and Trainee Responsibilities

(May 20) Translated Informed Consent Forms No Longer Required to be Submitted to DSRB

(Oct 19) Important Notice on Human Biomedical Research appropriate consent requirements

(Jan 19) Management of Incidential Findings – per HBRA requirement

(Nov 18) Human Biomedical Research (Exemption) Regulations 2018 & Appropriate Consent Requirements

(Jan 18) Best Practices on Data Management
  
(Jan 15) Responsible Conduct of Research (RCR) – Protection of Human Subjects
   

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(11) Study Conduct   

 

(Jun 20) Performing Subject Eligibility Assessment & Documentation

(Apr 20) What should be done if study procedure(s) are not conducted in accordance to IRB approved protocol

(Mar 19) Managing Conflict of Interest

(Sep 18) Ensuring timely submission of Study Status Report to the IRB for Study Renewal


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(12) Study Team & Responsibilities

 

(Jun 22) The Responsibilities of PI, Co-I and Clinical Research Coordinators?

(Jul 21) Minimum Training Requirements for PI and Study Team Conducting Human Biomedical Research (HBR) 

(Mar 17) Involvement of Collaborators in the Study Team

(Jan 17) Best Practices for Clinical Research Coordinator Handover


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(13) Subject Recruitment Procedures

 

(Jun 21) Pre-screening / Screening Process: Documentation and the Use of Subject's Identifiers

(Oct 20) Documentation for Pre-Screening and Screening Process of Research Subjects


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(14) Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSO)


HBR Expected SAE Roam Guide
     

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(15) Non-Complliance


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(16) Others



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