- This category has 143 topics, 1 reply, and was last updated 10 months, 1 week ago by
.
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- Forum
- Topics
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- Sponsors
- 2
- 2
- 3 years, 5 months ago
- Compliance With Requirement To Report Results On The EU Clinical Trials Reg
- Sponsor Audit – What Is In Scope?
- Annual QA Away Day Documents
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- 5
- 3 years, 5 months ago
- Documents From The QA Away Day On 12 September 2016
- Documents From The QA Away Day On 24 November 2017
- Documents From The QA Away Day On 5 July 2019
- Documents From The QA Away Day On 24 November 2020
- Guidance Doc For Prioritising Audits
- MHRA meeting minutes
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- 1
- 3 years, 5 months ago
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Laboratory GCP Compliance
Forum to discuss issues regarding GCP compliance in Laboratories
- 2
- 2
- 3 years, 5 months ago
- Core Steering Group Meeting Minutes
- 11
- 11
- 3 years, 5 months ago
- April 2015 Meeting Minutes
- May 2015 Meeting Minutes
- June 2015 Meeting Minutes
- January 2016 Meeting Minutes
- March 2016 Meeting Minutes
- May 2016 Meeting Minutes
- September 2016 Meeting Minutes
- November 2016 Meeting Minutes
- June 2017 Meeting Minutes
- April 2017 Meeting Minutes
- September 2017 Meeting Minutes
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MHRA CTU Inspections
A forum to discuss the MHRA CTU inspection process; to allow CTU staff to give feedback on the process and to share their experiences and to garner support from colleagues.
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- 4
- 3 years, 5 months ago
- Access To The Clinical Database
- Dossier Submission – Which Trials To Include?
- Trial Site Data
- MHRA Inspection Questions – March 2017
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Training & Development
Members are encouraged to share information and their recommendations of Training Courses.
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- 14
- 3 years, 5 months ago
- Preparing For Implementaion Of New CT Regulation
- Pharmacovigilance Workshop
- RQA Training Ideas
- List Of Audit Training Providers
- Short Course In Clinical Trials
- Electronic Training Records
- Randomised Controlled Trials – Short Course
- Training On The Data Protection Act With Relevance To Clinical Research
- Online Masters In Clinical Trials
- Reviewing/Updating CVs
- *Short Course: Clinical Trials In Mental Health*
- Training For Site Monitors
- E6 (GCP) And E9 (Statistical Principles For Clinical Trials) Training
- Trainer For Medical Device Trials
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Pharmacovigilance (PV)
Forum to discuss issues relating to Pharmacovigilance.
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- 31
- 2 years, 3 months ago
- Safety reporting in Hong Kong
- End of eSUSAR
- Collecting PV Information In Female Partners Of Male Trial Participants
- AE And SAE Coding
- Original SAE Forms
- US Academic Collaboration Trial – Safety Reporting Experiences
- **SAVE THE DATE** PV Workshop – 22 November 2016
- Pharmacovigilance Workshop – Registration Open
- Pharmacovigilance Workshop Documents – 22 November 2016
- Few Scenarios And Response From The MHRA
- MedDRA Free Webinars
- MHRA 2nd Blog On RSI
- Use Of MACRO For Pharmacovigilance?
- Use Of IB Updates As RSI For Multi-Country Trials
- Expectedness Assessments Of SAEs – Who Does Them?
- Interaction IMP With Radiotherapy?
- PV Processes In International Trials
- Experiences Of Protecting The Blind With Unexpected Events
- MedDRA Coding And RSI
- Toxicities Vs SAEs
- Green PV
- PV In Medical Device Trials
- SAE Processing Under Lockdown – Whilst Working From Home
- Use Of IB Updates As RSI For Multi-Country Trials
- Brexit And Pharmacovigilance
- Trend Analysis In PV
- Data Collected On SAE Forms And SAE Submission
- Remote SAE Reporting
- Processing Of Follow-Up SAE (Event Is Still Ongoing)
- ICSR Submissions
- SUSAR Submissions Using ICSR And Uploading XML Into EVWEB
- Regulation & Governance
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- 21
- 10 months, 1 week ago
- Inspection/Audit Using Routine Data
- Delegation Of Sponsorship Responsibilties
- Preparing For Implementaion Of New CT Regulation
- End Of Trial Reporting – Experience Of Using EudraCT
- Experience Of Uploading Onto EudraCT Using Xml Files.
- Template For IB For A Medical Device
- Over-Encapsulation Of Hormones
- Defining End Of Trial For Trials With Samples Being Analysed
- GDPR And CVs Held In The TMF
- GDPR – Transparency Obligations For Data Processors
- ***GDPR Update*** Extra Resources Re The Lawful Basis For Processing Data
- Posting CRFs
- GDPR And Data Protection Act 2018: Key Facts For Research
- Information Governance Arrangements
- Archiving Requirements For Medical Device Trials
- GDPR Update – MRC Regulatory Support Centre
- Data Controllers And Lawful Bases With EU Sites
- GDPR Transparency Information For Children
- Comparison Of ICH GCP And ISO 14155:2011 (Standards For Medical Devices)
- Data Security And Protection Toolkit
- EudraCT Access After Leaving The EU
- Risk Based Monitoring
- 2
- 2
- 3 years, 5 months ago
-
QA
Forum to discuss issues relating to Quality Assurance.
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- 46
- 2 years, 10 months ago
- Electronic Archiving software
- Share Contact Details For Providers Of Drug Packaging, Labelling And GMP
- External GCP Audit
- Audit Programmes
- GCP/CTIMP Regs Training Outside UK
- Document Management Systems – Any Recommendations?
- Vendor Audits
- Presentation Given To Directors – November 2015
- IMP Relabelling In Primary Care With No Pharmacy
- Electronic TMF
- Sponsor Assessment Of CTUs
- Core Steering Group Meeting Minutes
- Bulky Documents At Local Investigator Sites
- Electronic Archiving
- FDA Inspections
- Importing Medical Devices
- Pharmacy Input
- Sample Tracking Systems
- Safety Checks On Concom Med Doses
- Correspondence
- REC Rejections- Collection Of Initials And DOB
- Consent – By Treating Clinician
- Vendor Audits Of Commercial Companies
- Key Performance Indicators & Metric Measurement
- Governance Of CIs Not Employed By Sponsor
- Acceptable % Levels Of Data Entry Error For Internal Staff
- CTIMPs Risk Assessment
- Scope of Internal Audit Programme
- Justification On The Collection Of Individual Data Items
- Electronic Quality Management Software System (E.G. Q-Pulse)
- Retention Period For Internal Audit Reports
- Monitoring Activities Within A CTU
- Auditing Tools
- Medical Device Trials: Sponsor SOPs
- ABPI – Brexit & Clinical Trials Webinars 2019
- Anonymised Vs Pseudonymised Trial Data
- Vetting Of Lay Members Invited To Join Oversight Committees
- Doing Internal Audits Remotely
- Electronic Signatures
- Preparing Fro Brexit
- What Are Your Requirements Around GCP/Data Security’ Training For IT Staff?
- Q-Pulse Cloud From Ideagen
- NHSDigital Audit Query
- ECRF Sign Off By PI
- Wording For Patient Information Sheets For NHSD Data Applications
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Covid-19 queries
For queries and sources of information relating to undertaking QA activities during the Covid-19 pandemic.
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- 5
- 3 years, 5 months ago
