Transcript grace gcp - grace-lrti

WP 9-10 GRACE
GCP
Good Clinical Practice (GCP)
WP9-10
14 September 2007 Stockholm
WP 9-10 GRACE
GCP
GCP  Two basic goals:
1. Ensuring the integrity/quality of data
- Documentation (e.g. protocol, audit trail)
- Source/study documents to be stored for 15 years
2. Protection of the rights of patients participating in trials
- Approval of Ethical Committee (EC)
- Qualified investigators
- Informed consent procedure
WP 9-10 GRACE
GCP
Examples of standard GCP procedures:
-Approval of Ethical Committee (EC)
-Approval of national competent authority
(CA) for WP10 (study with medicinal
product)
-Approval other regulatory authorities
-Patient insurance to be obtained within
each network
-Informed consent procedure
WP 9-10 GRACE
Drug accountability
Drug logistics:
Manufacturer  pharmacist  NNF Practice  GP
First shipment:
- 34 boxes per network
- Each box containing 10 medication bottles (randomized)
Checks after receipt:
- Supplies must be checked against shipment form
- Box: network name and number correct
- Arrival at practice: Check trial medication codes of the bottles
inside (Always complete boxes are allocated to a practice)
- Packaging/bottles should be intact
WP 9-10 GRACE
Drug accountability
Documentation:
- Sign & date for receipt
- Fax copy to sponsor and file original form in Site File
Hand out of study medication by GP:
- Sequentially, see study medication code:112591,112628,112665, etc
- Explain correct use
- Explain correct storage
- Explain unblinding procedure
- Empty bottles/unused medication should be returned at visit 2
- Medication handed out & quantity returned should be documented on
the Drug Accountability Log > faxed to NNF every month > data entry
into GOS
- Start study medication after all samples are collected
Storage conditions:
Do not store above 30˚C. Protect from light and excessive humidity.
Please keep trial medication in a locked cabinet.
WP 9-10 GRACE
Unblinding
Unblinding:
When? In case the GP or another treating physician needs to know
whether the GRACE patient got an antibiotic or placebo.
How?
To break the code they can contact the 24 hour unblinding
service by telephone*. The following questions will be
asked:
1. Are you a GP involved in GRACE or another treating
physician
2. Date of birth patient
3. Trial medication code*
4. Reason for unblinding
After that the code will be broken without any further restrictions
* See label on medication bottle
WP 9-10 GRACE
SAE
SAE=serious adverse event
SAE classification:
-
Death
-
Life-threatening
-
In-patient hospitalisation
-
Disability/incapacity
-
Congenital anomaly/birth defect
-
Other medical events requiring intervention to prevent one of
the outcomes listed above
In case of a SAE, the SAE form (in Site File) should be completed
(study number handwritten) on the GRACE platform within 24
hours by GP or NNF* !
* After fax and telephone call from GP
WP 9-10 GRACE
GRACE short questionnaire
No return of diary after about 4 weeks
However, it’s very important (>80%) to collect the most relevant
data:
-
Symptoms first 3 days after consult/inclusion
-
Duration of illness
-
Study medication: yes or no
-
Side effects (diarrhoea, nausea, skin rash): yes or no
-
Reconsultation health service (GP, specialist, emergency
department etc)
 Send shortQ with letter (approved by EC) to patient
 Or complete shortQ by telephone
WP 9-10 GRACE
Monitoring
According to the WP10 protocol:
1. GPs will be visited by monitors independent from GRACE* to
perform source data verification of a randomly selected part of
the patients/data. During these visits also the Site Files could be
checked >> SOP in preparation
2. Also the presence of all signed consent forms will be verified.
Procedure: After inclusion a copy of the signed informed consent
will be faxed together with the registration form to the NNF, so
monitoring can take place.
* To be organized locally by the networks
WP 9-10 GRACE
Other GCP needs & SOPs
Slightly modified (if needed at all) GRACE-01 working practices will
and can be used for WP9 & 10 also. For example:
-
GP surgery visit checklist
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Signature list and delegation of responsibilities log
-
Training registration document
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Signed & dated CVs from all participating GPs (NEW!)
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GP & Network Site File
-
Screening logs
-
The Telephone Conversation SOP
WP 9-10 GRACE
Amendment
Old exclusion criterion: allergic to penicillin
New exclusion criterion: allergic to penicillin or
have a contra-indication for amoxicillin because
of a major interaction with other medication
 New version of WP10 protocol & patient CRF
needed