www.enos.ac.uk/

ENOS Indian Investigator Meeting

13th March 2010 “The role of the Local Centre”

ENOS Indian Investigator Meeting

13th March 2010 “The role of the Local Centre”

Sharon Ellender International Centre/Follow up

Coordinator

www.enos.ac.uk/

The National Coordinator’s role/responsibilities The National Coordinator’s role/responsibilities Promote trial Ensure necessary National Regulatory and Ethics

approvals have been gained Recruit Local Centres Assist Local Centres with set up Organise translations if necessary Monitor Local Centres (at least 3 times) Perform 90 day patient follow-ups by telephone Ensure practice of NCC and Local Centres is

according to ICH/GCP standards ENOS Insurance cover

www.enos.ac.uk/

The local centre’s role /responsibilitiesThe local centre’s role /responsibilities

Obtain and maintain Local approvals Ensure adherence to GCP/ICH standards Ensure all staff are trained & remain trained Ensure that Site files are current Recruit patients 1-2 per month Complete all patient forms online within the

time line Fax paperwork to International Coordinating

Centre

www.enos.ac.uk/

What makes a good Local CentreWhat makes a good Local Centre

Commitment to trial (time, staff, hospital) Experience in doing stroke trials Commitment to recruit 1-2 patients per

month consistently IT access: PCs, Internet, Fax,communication Fax/record and complete data in a timely

manner Be prepared for monitor visits by the NCC or

ICC

www.enos.ac.uk/

Local centre monitoringLocal centre monitoring

Findings are measured against GCP-ICH Aim of visit is to assess:

Conduct of Local Centre Maintain Trial File Validity of data - check data against source data Evidence of consent,signed and dated Identify major and minor protocol deviations, and

other abnormal findings

www.enos.ac.uk/

Local centre monitoringLocal centre monitoring

NCC or ICC will perform the monitoring

Local Centres with poor monitoring reports will have further inspections and could be closed down

International Coordinating Centre (ICC) will monitor NCCs once during the trial period

Report is completed by monitor using template and sent to Principal Investigator, National Coordinator, and Chief Investigator

www.enos.ac.uk/

Monitor Form uploadMonitor Form upload

www.enos.ac.uk/

FindingsFindings

Document/Version Control Incorrect Version Numbers, e.g. consent forms

Times of stroke and consent Not written in medical records

Delegation of responsibilities Not defined

Trial File Non-existent, or not up to date

Dates and times Inconsistent between medical notes and trial data entered online and in the patient trial file

www.enos.ac.uk/

FindingsFindings

Poor recognition of antihypertensive agents Recognition of antihypertensives BP measurements Failure to take BP measurements at peak action of

patch (1-2 hours after placement of patch) Failure to take 2 BP measurements Failure to use OMRON machine Failure to obtain 7 days of BPs Failure to correctly record randomised treatment use on day

7 form Failure to record randomised treatment on the

drug chart

www.enos.ac.uk/

FindingsFindings

Equipment Broken printers,omrons, settings incorrect.

Local Centre staff training Staff not GCP trained

Includes Principal Investigator! Staff do not have GCP certificate All staff need an up to date CV (2 yearly)

NCC staff training Outcome assessor not mRS trained Outcome assessor does not have mRS certificate

www.enos.ac.uk/

Quality: Protocol ViolationsQuality: Protocol Violations

Protocol Violations are major deviations from the trial design

Must be reported to the DMC We must avoid them to maintain the trial’s

quality and to protect patients Sites should report them to the ICC and NCC

if they occurred accidentally May be discovered on the database or at a

site monitoring visit

www.enos.ac.uk/

Examples of Protocol ViolationsExamples of Protocol Violations

Patient under 18 years of age Randomisations >48 hours from onset of symptoms GCS <8 at randomisation No clinic weakness evident at any point Weakness present for <1 hour in total Limb weakness not present at time of enrolment Failure to obtain consent or assent of patient Systolic BP 140 - 220 mmHg at inclusion Dependent (mRS >2) prior to stroke Pre-existing antihypertensives not identified GTN patch not given during first 4 days (if

randomised)

www.enos.ac.uk/

Protocol ViolationsProtocol Violations

Patient pregnant or breastfeeding at inclusion Known severe concomitant illness Known non-stroke intracranial pathology,ie brain

tumour Patient already involved in another drug trial (or

within 3 months) at time of randomisation Planned use of antihypertensive agents when

randomised to ‘stop’, i.e. antihypertensives continued

No cranial imaging Failure to complete SAEs if they occur Follow up assessments are performed outside the

specified times

www.enos.ac.uk/

Quality: Protocol DeviationsQuality: Protocol Deviations

More minor deviations from trial protocol May occur due to unforeseen events or

mistakes. File notes can be used.

www.enos.ac.uk/

Examples of Protocol DeviationsExamples of Protocol Deviations

Patient does not receive GTN patch on days 5 to 7 of trial, if randomised to do so

Clinician unintentionally or intentionally (in an emergency situation) introduces new antihypertensives within first 7 days of trial, or recommences pre-trial antihypertensives if randomised not to do so

Patient does not receive usual antihypertensives if randomised to do so

There are not 3 OMRON blood pressure measurements at randomisation and 2 OMRON blood pressure measurements daily during first 7 days

Follow up assessments are submitted outside the specified time

Patient goes home <4 days after enrolment

www.enos.ac.uk/

SAE formsSAE forms

ADVERSE EVENTS Reported on the Day 7 Form only. SERIOUS ADVERSE EVENTS 1.Death

2.Life threatening events 3.Requires in patient hospitalization, prolonging of existing hospitalization 4.Results in persistent or significant disability /incapacity 5.Is a congenital anomaly/birth defect

Submit within 24 hours of the event Report SAE’S until completion of the day 90 follow up

www.enos.ac.uk/

In conclusionIn conclusion

Commitment to trial (time, staff, hospital)Commitment to recruit 1-2 patients per month, consistently Fax/record and complete data in a timely mannerBe prepared for monitor visits by the NCC or ICC

Good Luck!!