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 GRACE
Inclusion of Patient or Control (1)
Patient goes to GP
GP checks in- and exclusion criteria
GRACE WP9/10 for patients or controls
and informs patient about study
(Control) Patient signs informed
consent
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 form
on paper
GP faxes registration form and IC to NNF
GP stores registration form localy in GRACE
specific file
GP/NNF enters registration data
within 24 hrs into GOS:
GOS will generate tasks and surveys for either
Control 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 out
of randomised packs
GP completes CRF
GP labels the registration form and IC with the trial
medication code label
GP/NNF enters data into GOS within 2 days
WP 9-10 GRACE
Patient: Visit 1 (2)
GP/Nurse labels
samples
use V1 labels !
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 completes Inv
Requisition form
GP/Nurse sends to local lab:
- samples
- remainng V1 labels
- lab requisition form
- sputum result form
GP/Nurse/NNF enters Inv
requisition V1 data onto
GOS
GP/Nurse stores Inv
requisition form in GRACE
specific file
WP 9-10 GRACE
Patient: Visit 1 (3)
GP arranges appointment for
X-ray within 3 days
X-ray is made and X-ray form is
completed
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
WP 9-10 GRACE
Patient: Visit 1 DIARY
Patient fills in diary (28 days)
Patient sends diary to NNF
NNF registers diary into GOS
NNF enters data of Diary
WP 9-10 GRACE
Patient: Visit 1 DIARY/ShortQc
If Patient sends diary NOT to NNF
NNF contacts Patient for Short QC
NNF enters data of Short Qc
NNF:
- enters first question of Diary into GOS
(diary not received)
- finalises the survey
GOS will generate
Short QC task
Diary can be opened again
by using the survey listing
when diary returns later
If NNF fails to contact Patient
NNF:
- enters first question of Short Qc into GOS
(No Short Qc data obtained)
- finalises the survey
WP 9-10 GRACE
Patient: SAE
Patient has SAE
GP registers SAE on
‘SAE form’
GP faxes within 24 hrs SAE
form to NNF and confirms with
phone
GP/NNF enters data on
‘SAE form 1’ into GOS within
24 hours
WP 9-10 GRACE
Patient: SAE
After finalizing SAE form 1 GOS will
generate the second SAE form
Use this form to register the
second SAE.
A third SAE should be reported
directly to the NNF
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
WP 9-10 GRACE Online System
Patients flow
- Visit 2
WP 9-10 GRACE
Patient: Visit 2 (1)
GP performs lung function testing
(before salbutamol)
GP registers result on Visit 2
‘Spirometry’ form
GP let PT inhale 400 µg salbutamol
GP/Nurse labels samples with
subject code
GP/Nurse takes samples of patient:
USE V2 LABELS !
- 2 nasopharygeal swabs
- 10 ml SST tube of venous blood
GP/Nurse completes
Inv requisition form
GP/Nurse sends to local lab:
- samples
- remainng V2 labels
- lab requisition form
GP/Nurse/NNF enters Inv
requisition V2 data onto
GOS
GP/Nurse stores Inv
requisition form in GRACE
specific file
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 registeres medication
capsules present on drug
accountability form
GP/NNF enters data from
spirometry form into GOS
GP/NNF enters number of
capsules 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 CRF
GP/NNF enters data from control
CRF into GOS within 2 days
GP/Nurse labels
samples
use V0 labels !
GP/Nurse sends to local lab:
- samples
- remainng V0 labels
- lab requisition form
GP/Nurse takes samples of patient:
- 2 nasopharyngeal swabs
- EDTA tube of venous blood
GP/Nurse completes Inv
Requisition form
GP/Nurse/NNF enters Inv
requisition V0 data onto GOS
GP/Nurse stores Inv
requisition form in GRACE
specific file
WP 9-10 GRACE Online System
Samples flow
- Visit 0, 1 and 2
WP 9-10 GRACE
Samples: Local lab
Local lab faxes local lab
requisition form to NNF
Local lab registers the arrival of samples on
local lab requisition form
NNF registers the arrival of
samples into GOS
Local lab stores local lab
requisition form into local binder
Local lab handles and analyses
the samples, labels the new
tubes and stores the samples
until transport to central lab
Local lab send sputum results
to NNF (only V1)
NNF registers sputum
result into GOS
WP 9-10 GRACE
Samples: Central lab
Local lab transports batches of
samples to central lab
Central lab receives batches of
samples from local lab
Central lab registers the arrival of
samples into GOS
Central lab handles the samples,
labels the new tubes and stores the
samples until transport to other WP’s
Central lab transports batches of
samples to WP 3-7 labs
WP 9-10 GRACE
Samples: analyses
WP lab analyses samples
Lab stores results in local
database
Lab sends local database to WP2
WP2 stores results central and
merges results to other CRF data
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
2
19
Human tasks
4
8
WP 9-10 GRACE
Survey tasks on GOS: Visit 1
GP
NNF
Central lab
Sample V1
registration
GP
Sample V1
registration
Loc Lab
Sample V1
registration
Central lab
X-ray result
CRF
Sputum results
SAE 1
Diary
SAE 2
ShortQc
All surveys for the GP will also appear on the
tasklist 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
Sample V2
registration
Loc Lab
Sample V2
registration
Loc Lab
Sample V2
registration
Central lab
Drug
accountability
Sprirometry
result
All surveys for the GP will also appear on the
tasklist 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 V0
registration
GP
Sample V0
registration
Loc Lab
All surveys for the GP will also appear on the
tasklist of the NNF
Sample V0
registration
Central lab
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 GRACE
Remember
• 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 GRACE
Communication
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)