Good Clinical Practice (GCP)
Click here to load reader
description
Transcript of Good Clinical Practice (GCP)
21/04/2016 Good Clinical Practice (GCP)
http://forums.mhra.gov.uk/forumdisplay.php?1GoodClinicalPractice(GCP) 1/5
Forum Good Clinical Practice (GCP)
Topics Threads /Posts
Last post
You will need to register or login above with your username to post on this forum.
If you require further help please view our quick start guide or view the online help section.
Forum: Good Clinical Practice (GCP)The GCP forum has been created as a tool to help those involved in clinical trials of Investigational MedicinalProducts to comply with the clinical trials legislation and GCP requirements. It provides the ideal opportunity forextended communication between researchers and allows users to put forward their comments and get ?reallife? examples of ways in which they can manage robust quality procedures that ensure compliance and whichdovetail with their own business needs and resources.
This forum should not be used for direct questions to the GCP Inspectorate/Clinical Trials Unit, reporting seriousbreaches or making formal complaints. These should follow the formal routes that are already in place.
Please read the Good Clinical Practice (GCP) Forum introduction and rules before posting on this forum.
Medicines and Healthcare products RegulatoryAgency
User Name Password Log in
Remember Me?Forgot login details?
RegisterHelp
What's new?
FAQ Forum actions Quick links Advanced Search
Threads 1 to 11 of 11
Forum Tools Search Forum
GCP Forum introduction and rules PLEASEREAD BEFORE POSTING ON THIS FORUMPlease read the Good Clinical Practice (GCP) forumintroduction and rules before posting on this forum.
Threads:1
Posts: 1
Good Clinical Practice(GCP)... by
14th Oct 2011, 11:22 AMMHRA Super Moderator
Clinical laboratories Threads:4
Posts: 8
CE marks on central lab...
by 15th Apr 2015, 03:34 PM
acadwallader
Computer system validation (CSV) and ITsystems
Threads:5
Systems used inacademic...
Forum
21/04/2016 Good Clinical Practice (GCP)
http://forums.mhra.gov.uk/forumdisplay.php?1GoodClinicalPractice(GCP) 2/5
Posts: 17 by 15th Apr 2016, 09:13 AM
MHRA Moderator
Contracts and agreements (includinginsurance)
Threads:3
Posts: 7
Contract terms SAE...
by 30th Jul 2012, 04:13 PM
Nev Young
Data management Threads:7
Posts: 17
Data Management Plan ...
by 9th Oct 2015, 10:43 AM
Alika Cooper
Electronic Systems (inc. eCRF, esource, ePRoand ehealth records/EHR)
Threads:1
Posts: 1
Electronic HealthRecords... by
15th Oct 2015, 11:35 AMMHRA Super Moderator
Equipment maintenance Threads:5
Posts: 7
Refrigerator by 9th Feb 2015, 02:50 PM
Masajepa
Ethics approval Threads:5
Posts: 9
MHRA and HRA Positionon Who... by
15th Jul 2015, 03:11 PMMHRA Super Moderator
Inspection process Threads:3
Posts: 8
Inspection/audit CAPAfollow... by 4th Nov 2014, 12:13 PM
Vyara Stefanova
Investigational Medicinal Products (IMP) Threads:35
Posts:101
IMP sourcing by 22nd Mar 2016, 10:51 AM
alex
Investigator Sites (inc Principal Investigatorresponsibilities, consent, source data andCRFs)
Threads:47
Posts:136
Reconsenting due tochange of... by 16th Apr 2016, 08:26 PM
a123456
Legislation Threads:5
Posts: 18
The EU Clinical Trials... by 2nd Mar 2016, 01:35 PM
a123456
Monitoring Threads:11
Posts: 53
protocol Deviations dueto... by 2nd Mar 2016, 12:27 AM
judith_sylvia
Pharmacovigilance Threads:11
Posts: 24
Safety reporting for... by 3rd Aug 2015, 06:29 PM
CPi
Programme management Threads:0
Posts: 0
Never
Quality Systems (including QA, SOP andTraining)
Threads:15
Posts: 33
SOPs/Policies andeffective... by 20th Nov 2015, 01:49 PM
thepharmaexpert
Risk adaptive approach Threads: Examples of type C risk...
21/04/2016 Good Clinical Practice (GCP)
http://forums.mhra.gov.uk/forumdisplay.php?1GoodClinicalPractice(GCP) 3/5
4Posts: 27
by 19th Nov 2015, 01:07 PM
Nicola Sims
Riskbased inspections Threads:2
Posts: 2
Clinical Trial Unit... by 8th Jun 2015, 02:01 PM
MHRA Moderator
Regulatory documents (including protocol,clinical study reports and publications)
Threads:3
Posts: 6
Distribution of IB updatesto... by 17th Apr 2015, 02:17 PM
jhulbert
Sponsor oversight Threads:4
Posts: 9
Paperless files by 13th Nov 2015, 06:38 PM
a123456
Statistics Threads:1
Posts: 2
Statistical Analysis Plan...
by 13th Nov 2015, 06:33 PM
a123456
Trial Master File (TMF) and archiving Threads:22
Posts: 68
Retention of Trial Records
by
25th Nov 2015, 12:50 PMMHRA Super Moderator
Title / Thread starter Replies /Views
Last post by
Sticky: Questions on Clinical Trials if we leave theEUStarted by MHRA Super Moderator, 4th Mar 2016 12:49
PM
Replies:0
Views:2,281
4th Mar 2016, 12:49 PM MHRA Super Moderator
Sticky: CTA submission now only accepted viaCommon European Submission Platform (CESP)Started by MHRA Super Moderator, 8th Jan 2016 09:30
AM
Replies:0
Views:4,401
8th Jan 2016, 09:30 AM MHRA Super Moderator
Sticky: MHRA make changes to clinical trialsphase I accreditation schemeStarted by MHRA Super Moderator, 30th Oct 2013 03:30
PM
Replies:0
Views:7,517
30th Oct 2013, 03:30 PM MHRA Super Moderator
A good template for IMP Pharmacy ManualsStarted by judith_sylvia, 24th Feb 2016 09:17 AM
Replies:0
Views:2,343
24th Feb 2016, 09:17 AM judith_sylvia
Missing Medical NotesStarted by Praseeda12, 16th Dec 2015 02:15 PM
Replies:1
Views:5,392
17th Dec 2015, 05:00 PM a123456
Mixing ink and digital signaturesStarted by Heather, 11th Aug 2015 02:33 PM
Replies:1
Views:6,592
27th Nov 2015, 10:44 AM rammellconsult
Research samplesStarted by ecsy911, 11th Jun 2015 11:28 AM
Replies:2
Views:3rd Nov 2015, 09:50 AM violetpt
21/04/2016 Good Clinical Practice (GCP)
http://forums.mhra.gov.uk/forumdisplay.php?1GoodClinicalPractice(GCP) 4/5
Default Style MHRA website Contact us Privacy statement Top
6,590
Moved: SUSARs sent to pharmaciesStarted by Nikki Dewick, 23rd Oct 2015 12:43 PM
If there's no acting Principal Investigator....Started by Federica Bitonti, 26th Jun 2015 03:04 PM
Replies:1
Views:5,907
13th Jul 2015, 09:25 AM a123456
Moved: Exclusion criterion participation in previousclinical trial within three monthsStarted by SRH, 25th Feb 2015 03:19 PM
Moved: clinical trials in homecare pharmaciesStarted by Kiran Bharaj, 23rd Jan 2015 11:59 AM
Moved: Medical Images RequirementsStarted by castede1, 22nd Dec 2014 08:17 PM
Moved: Deleted records by site in errorStarted by blsm002, 22nd Sep 2014 06:49 AM
Moved: Consent in Emergency ResearchStarted by Hugh Davies, 2nd Oct 2012 02:41 PM
Quick navigation Good Clinical Practice (GCP) Top
Show threads from the...Beginning
Sort threads by:Last post time
Order threads in... Ascending Order Descending Order
Moderators of this ForumMHRA Moderator
Forum information and options
Thread Display Options
Show Threads
Contains unread postsContains no unread postsHot thread with unread postsHot thread with no unread postsThread is closedYou have posted in this thread
Icon legend
You may not post newthreadsYou may not post repliesYou may not postattachmentsYou may not edit yourposts
BB code is OnSmilies are Off[IMG] code is On[VIDEO] code is OnHTML code is On
Forum Rules
Posting Permissions
21/04/2016 Good Clinical Practice (GCP)
http://forums.mhra.gov.uk/forumdisplay.php?1GoodClinicalPractice(GCP) 5/5
Powered by vBulletin® Version 4.2.1 Copyright © 2016 vBulletin Solutions, Inc. All rights reserved.