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WP 9-10 GRACE Online System
GRACE Online System
WP9-10
Frank Leus
14 September 2007 Stockholm
WP 9-10 GRACE Online System
• Visit codes
• Labels
• GRACE packs
• Study flows
• Survey tasks and human tasks
WP 9-10 GRACE Visit Codes
Visit codes
Patients
V1 = Visit 1 Inclusion of patient
V2 = Visit 2 4 weeks after inclusion of patient
Controls
V0 = Inclusion of control
WP 9-10 GRACE Yellow labels for forms
Yellow labels for patients
15 labels per patient for V1 and V2
Labels provided for 350 patients per Network
Labels consist of Patient Study Number followed by ‘Pt’ e.g. L0213 Pt
Same labels should be used for V1 and V2
WP 9-10 GRACE Yellow labels for forms
NNF attaches yellow patient labels to the following forms:
Informed Consent form 2x, Patient registration form 1x CRF 1x Diary 1x X-ray requisition form 1x Spirometry requisition form 1x Investigator requisition form 2x (V1 + V2) Local lab requisition form 2x (V1 + V2) Sputum results 1x
And to the blue patient pack 1x
WP 9-10 GRACE Yellow labels for forms
Yellow labels for controls 10 labels per control Labels provided for 350 controls per Network Labels consist of Patient Study Number followed by Ctr
e.g. L0214 Ctr
NNF attaches labels to the following forms: Informed Consent form 2x, Patient registration form 1x Control CRF 1x Investigator requisition form 1x Local lab requisition form 1x
And to the white control pack 1x
WP 9-10 GRACE White labels for samples
White labels
Patients
10 labels provided per patient for V1
5 labels provided per patient for V2
Controls
5 labels provided per control for V0
For each visit (V1,V2 and V0) there will be 75 numbers provided
WP 9-10 GRACE White labels for samples
White labels Labels consist of :
‘GRACE’
Patient Study number
Visit Number
e.g. GRACE L0213 V1
GP/Nurse attaches white labels to samples
The remaining labels will be send together with samples to local lab
WP 9-10 GRACE GRACE packs
To be prepared by NNF
Patient packs (blue):
All forms to which yellow labels should be attached
Patient Information Leaflet
TempaDot disposable thermometer (use new ones)
Stamped self adressed envelope for return of patient diary
Sample packs V1 and V2, including besides sample material: Requisition forms (GP and Local Lab) Only for V1 sputum result form White labels
WP 9-10 GRACE GRACE packs
To be prepared by NNF
Control packs (white):
All forms to which yellow labels should be attached
Patient Information Leaflet
Sample pack, including besides the sample material: Requisition forms (GP and Local Lab) White labels
WP 9-10 GRACE Online System
Inclusion flow(for patients and controls)
WP 9-10 GRACEInclusion of Patient or Control (1)
Patient goes to GP
GP checks in- and exclusion criteriaGRACE WP9/10 for patients or controls
and informs patient about study
(Control) Patient signs informedconsent
GP stores informed consent local in(control) patient specific GRACE file
WP 9-10 GRACE Inclusion of Patient or Control (2)
GP/NNF completes registration formon paper GP faxes registration form and IC to NNF
GP/NNF enters registration datawithin 24 hrs into GOS:
GP stores registration form localy in GRACEspecific file
GOS will generate tasks and surveys for eitherControl or Patient based on ‘Subject Type’
WP 9-10 GRACE Inclusion of Patient or Control (3)
WP 9-10 GRACE Online System
Patients flow- Visit 1
WP 9-10 GRACE Patient: Visit 1 (1)
GP takes trial medication outof randomised packs
GP labels the registration form and IC with the trialmedication code label
GP completes CRF GP/NNF enters data into GOS within 2 days
WP 9-10 GRACE Patient: Visit 1 (2)
GP/Nurse takes samples of patient:
- 2 nasopharyngeal swabs - 10 ml SST tube of venous blood - EDTA tube of venous blood - Sputum sample
GP/Nurse labelssamples
use V1 labels !
GP/Nurse sends to local lab: - samples - remainng V1 labels - lab requisition form - sputum result form
GP/Nurse completes InvRequisition form
GP/Nurse stores Invrequisition form in GRACE
specific file
GP/Nurse/NNF enters Invrequisition V1 data onto
GOS
WP 9-10 GRACE Patient: Visit 1 (3)
GP arranges appointment forX-ray within 3 days
NNF enters result of X-ray into GOS
- GP arranges appointment for patient consultation over 4 weeks
- GP hands out trial medication to patient
- GP hands out diary to patient
X-ray is made and X-ray form iscompleted
WP 9-10 GRACE Patient: Visit 1 DIARY
Patient fills in diary (28 days)
Patient sends diary to NNF NNF enters data of DiaryNNF registers diary into GOS
WP 9-10 GRACE Patient: Visit 1 DIARY/ShortQc
If Patient sends diary NOT to NNF
NNF: - enters first question of Diary into GOS (diary not received) - finalises the survey
GOS will generateShort QC task
NNF enters data of Short QcNNF: - enters first question of Short Qc into GOS (No Short Qc data obtained) - finalises the survey
If NNF fails to contact PatientNNF contacts Patient for Short QC
Diary can be opened againby using the survey listingwhen diary returns later
WP 9-10 GRACE Patient: SAE
GP registers SAE on ‘SAE form’
GP/NNF enters data on ‘SAE form 1’ into GOS within
24 hours
Patient has SAE
GP faxes within 24 hrs SAEform to NNF and confirms with
phone
WP 9-10 GRACE Patient: SAE
After 6 weeks, the SAE task will turn red
If no SAE occured you can delete the SAE task in the following way:- Open SAE survey (using tasklist)- Fill in first question (No SAE occured)- Finalise survey
No new SAE task will be generated
After finalizing SAE form 1 GOS willgenerate the second SAE form
Use this form to register thesecond SAE.
A third SAE should be reporteddirectly to the NNF
WP 9-10 GRACE Online System
Patients flow- Visit 2
WP 9-10 GRACE Patient: Visit 2 (1)
GP/Nurse takes samples of patient:
- 2 nasopharygeal swabs - 10 ml SST tube of venous blood
GP/Nurse labels samples withsubject code
USE V2 LABELS !
GP performs lung function testing (before salbutamol)
GP registers result on Visit 2‘Spirometry’ form
GP let PT inhale 400 µg salbutamol
GP/Nurse sends to local lab: - samples - remainng V2 labels - lab requisition form
GP/Nurse completesInv requisition form
GP/Nurse stores Invrequisition form in GRACE
specific file
GP/Nurse/NNF enters Invrequisition V2 data onto
GOS
WP 9-10 GRACE Patient: Visit 2 (2)
GP performs second lung function testing (15 min after salbutamol inhalation) - FEV1 and FVC
GP registers result on‘Spirometry’ form
GP/NNF enters data fromspirometry form into GOS
GP/NNF registeres medicationcapsules present on drug
accountability form
GP/NNF enters number ofcapsules on drug accountabilty
form into GOS
WP 9-10 GRACE Online System
Controls flow- Visit 0
WP 9-10 GRACE Patient: Visit 0
GP completes control CRFGP/NNF enters data from control
CRF into GOS within 2 days
GP/Nurse takes samples of patient:
- 2 nasopharyngeal swabs - EDTA tube of venous blood
GP/Nurse labelssamples
use V0 labels !
GP/Nurse sends to local lab: - samples - remainng V0 labels - lab requisition form
GP/Nurse completes InvRequisition form
GP/Nurse stores Invrequisition form in GRACE
specific file
GP/Nurse/NNF enters Invrequisition V0 data onto GOS
WP 9-10 GRACE Online System
Samples flow- Visit 0, 1 and 2
WP 9-10 GRACE Samples: Local lab
NNF registers the arrival ofsamples into GOS
Local lab stores local labrequisition form into local binder
Local lab handles and analysesthe samples, labels the new
tubes and stores the samplesuntil transport to central lab
NNF registers sputumresult into GOS
Local lab registers the arrival of samples onlocal lab requisition form
Local lab send sputum resultsto NNF (only V1)
Local lab faxes local labrequisition form to NNF
WP 9-10 GRACE Samples: Central lab
Local lab transports batches ofsamples to central lab
Central lab receives batches ofsamples from local lab
Central lab registers the arrival ofsamples into GOS
Central lab transports batches ofsamples to WP 3-7 labs
Central lab handles the samples,labels the new tubes and stores the
samples until transport to other WP’s
WP 9-10 GRACE Samples: analyses
WP2 stores results central andmerges results to other CRF data
Lab sends local database to WP2
WP lab analyses samples
Lab stores results in localdatabase
WP 9-10 GRACE Online System
Surveys and tasks- Visit 0, 1 and 2
WP 9-10 GRACE Surveys and human tasks on GOS
WP8 WP9-10
Survey tasks
4 8Human tasks
2 19
WP 9-10 GRACE Survey tasks on GOS: Visit 1
GP NNF
CRFX-ray result
Diary
Sample V1registration
Loc Lab
Sputum results
Central lab
Sample V1registrationCentral lab
Sample V1registration
GP
SAE 1
ShortQc
SAE 2
All surveys for the GP will also appear on thetasklist of the NNF
WP 9-10 GRACE ‘Human’ tasks for NNF: Visit 1
Remind GP Patient CRF
When: 7 days after inclusion, if CRF not finalised
Check samples V1 GP (new)
When: 1 day after inclusion, if sample registration V1 GP not finalised
Register Symptom Diary
When: Direct after inclusion, if Symptom Diary not finalised
Inform Patient about Symptom Diary
When: 4 days after inclusion, if Symptom Diary not finalised
Remind Patient
When: 28 days after inclusion, if Symptom Diary not finalised
WP 9-10 GRACE Survey tasks on GOS: Visit 2
GP NNF Central lab
Sprirometryresult
Drugaccountability
Sample V2registration
Loc Lab
Sample V2registrationCentral lab
Sample V2registration
Loc Lab
All surveys for the GP will also appear on thetasklist of the NNF
WP 9-10 GRACE ‘Human’ tasks for NNF: Visit 2
Check samples V2 GP (new)
When: 36 days after inclusion, if sample registration V1 GP not finalised
WP 9-10 GRACE Survey tasks on GOS: Visit 0
GP NNF Central lab
Control-CRF
Sample V0registration
Loc Lab
Sample V0registrationCentral lab
Sample V0registration
GP
All surveys for the GP will also appear on thetasklist of the NNF
WP 9-10 GRACE ‘Human’ tasks for NNF: Visit 0
Remind GP Control CRF (new)
When: 7 days after inclusion, if control CRF not finalised
Check samples V0 GP (new)
When: 1 day after inclusion, if sample registration V1 GP not finalised
WP 9-10 GRACE New Survey listing
• Make your selection
• Click on ‘Search’
WP 9-10 GRACE New Survey listing (2)
- Surveys with status ‘new’ will not be shown in survey listing
- Print/view possibility will soon be available
WP 9-10 GRACERemember
• Always include subjects to the correct GP
Each GP should have their own account
• After re-opening a ‘closed’ survey always ‘finalise’ the survey
• When training with GOS use:
The ‘Demo’ network
Subject numbers preceeded with an ‘X’
Trial medication numbers in the range X001- X999
Please, delete your test subjects when you are finished
• Keep up with your tasklist!
WP 9-10 GRACE Tasklist NNF
Direct after inclusion of a Patient
WP 9-10 GRACE Tasklist NNF
1 week after inclusion of a Patient
WP 9-10 GRACE Tasklist NNF
6 weeks after inclusion day of a Patient
WP 9-10 GRACECommunication
In case of GOS related questions:
e-mail to Jan-Willem Maaskant ([email protected])
e-mail to Frank Leus ([email protected])
Call the GRACE phone (+31627744069)