Pioneer - IM Krakow - EDC Overview

PIONEER CCD-06001AA1-01 Study Specific EDC Training
Site User eCRF Training – Rave Version 2016.4
Paulina Awsiukiewicz, eClinical Technical Trainer, Chiltern

Sofie Corluy, Sr Clinical Team Leader, Chiltern
8th December 2016 – Krakow, Poland

Agenda 2
Quiz at the end of the training!
eCRF Training – 8th December 2016 – Pioneer IM - Confidential

Computer Basics 3
 3 Tools needed
• Computer (Windows, Mac, Linux, virtually any OS)
• Internet Browser (Internet Explorer and Firefox recommended)
− If using Internet Explorer Version 10 or newer ‘Compatibility Mode’ may be
needed.
• Broadband Internet Connection

Activating Study Access 4
 Basic steps:
• Receive email invitation from iMedidata-notification@mdsol.com to
create your account (Check spam/junk folder!)
− If needed, contact your CRA or Pioneer.eCRFTraining@Chiltern.com with
request to resend the iMedidata invitation email
• Select link in the email and activate your account
• Reminder: Activation link is valid 30 days! Password is confidential!

Join the Study 5
 Accept to join the study under tasks

 eLearning modules are available under tasks
• Please remind PIs to activate their accounts as soon as possible to
ensure they are able to report and sign any initial and updated SAE as
per ICH GCP 4.9.1.

Complete eLearning (Site) 6
 Before site access can be granted, a

role specific eLearning needs to be
completed
 Available in the eLearning section of
iMedidata homepage
 No need to repeat if already completed
for another study
eLearning
Role Permissions eLearning Course Name
optional/mandatory
Investigator (eSign only) Review & eSign Mandatory Rave EDC Essentials for Investigators
Rave EDC Essentials for Investigators

Data Entry &
Investigator - Full Mandatory Rave EDC Essentials for Clinical
eSign
Research Coordinators
Rave EDC Essentials for Clinical

Study Coordinator Data Entry Mandatory
Research Coordinators

Confirm Study Access 7
 ALWAYS verify if study name, site number and your name are correct
 If incorrect site information:
• Do NOT proceed
• Notify your Monitor or Pioneer.eCRFTraining@Chiltern.com immediately

Question Time! 1 of 2 8
 How do you request access to Rave?
Contact Medidata
Via Monitor
directly

 Within what period do I have to activate my iMedidata account

before the activation link expires?
Within 180 days Within 30 days

Agenda 10

Creation of Patient Casebook 11
NOT
 Patient Casebook in RAVE is created via IWRS manually in
• When a new patient is first registered in IWRS at V0, RAVE
this patient is automatically created in eCRF within 5 minutes
 Patient Number is composed of 9 digits:
• first 6 digits = SITE NUMBER (3 digits = Country Code & 3 digits = Site)
• last 3 digits added sequentially identify the PATIENT

eCRF Folder Tree 12
Visit 0 - Pre-screening
End of Study
Study Medication Replacement Log
Prior and Concomitant Medications
Concomitant Procedures
Available once patient is
Adverse Events created in IWRS
COPD Exacerbations
Pneumonia Investigation
Investigator’s Comments
Visit 1 - Screening (Week-2) Available once Visit 0 is

completed
Available after confirmation

Visit 2 - Randomization
in Visit 1, End of Visit
Screening form that patient
continues
Available after confirmation

V3, V4, V5, V6, V7/Early Termination
in Visit 2, Randomization
form that patient has been
randomized

IWRS Data Integration 13
 As soon as recorded in IWRS, the following data will be transferred

to the eCRF:
Visit 0 PRE- SCREENING:

- Visit Date
- Patient ID number
- Date of Visit
- ICF date
- Date of birth (only year in Hungary
and Germany)
- Age
- Gender
VISIT 1 SCREENING :
- Visit Date
VISIT 2 :
- Randomisation Data
Important Note: Any changes to imported data must be made in IWRS

system, not directly in Rave

Wash-out not Respected 14
 Reminder: no background and study medication should be taken on the day of a study
visit prior the visit
 If visit is not performed because of washout not respected:
• no data should be recorded in eCRF and visit should be rescheduled
• Visit date should correspond to date of visit actually performed
 If wash-out not respected for the second time:
• at V1 (Screening) - Patient is a Screen Failure
• at V2 – Patient is discontinued
• after V2 – Patient can remain on the study; study medication (visit specific) should
be entered in the form and a comment should be added on Investigator’s Comments
page with reason why wash-out not respected

COPD History Form 15
 Provide date (Month and Year) of first diagnosis

 Remember to add corresponding COPD medications taken prior to
Screening Visit in Prior and Concomitant Medications page.
● Provide details of the number of

moderate and severe
exacerbations in the previous 12
months
● Provide details of the last
documented exacerbation
Documented COPD exacerbation

=
Medical records, prescriptions, medical

declarations available at the site

Medical/Surgical History and Concomitant Diseases
16
 Form available after confirmation that patient has relevant medical

conditions
 Description of Diseases and/or Procedures:

 Record DIAGNOSIS rather than symptoms.
 Report one disease per line.
 Make every effort to provide a complete date: Month and Year required
 Ongoing: If an ongoing condition resolves after the informed consent was signed, then the the
status should remain as ’Ongoing’ as the condition was ’Ongoing’ at the time of Screening

Medical History vs. Adverse Events 17
 At Visit 1:
• In case of any CLINICALLY SIGNIFICANT ABNORMALITY, it should be
recorded in the MH form unless its start date is after the informed
consent signature and it is not due to a pre-existing condition. In this case
it must be recorded as Adverse Event in the AE Form.
• If it is a pre-existing abnormality which worsened after Informed Consent
signature, please report the underlying condition in the MH and the
worsening in the AE form.
 After Visit 1(Screening)

• In case of any new CLINICALLY SIGNIFICANT ABNORMALITY or
worsening, it should be recorded as AE. In case of worsening, the worse
condition should be recorded in the AE form updating the existing record

Psychiatric assessment 18
 Please complete the MH form (if the disease starts prior the
Informed Consent signature) or add the adverse event (if the event
starts after the Informed Consent signature)
 If the patient develops suicidal ideation or behavior, he/she should

be discontinued and End of Study form must be filled in.

Central Laboratory Assessments (1/2) 19
 Blood samples will be analyzed in Central Laboratory

• Routine Haematology
• Chemistry
• Thyroid function test to be done only at V1
 Collected at V1, V2, V5 and V7
 For patients discontinued at V3, V4 and V6 blood sample for
standard haematology, blood chemistry and biomarkers will be
collected in respective Visit folder

Central Laboratory Assessments (2/2) 20
 Urinalysis performed by Central Lab at V1, V2 and V7
 Dipstick at other visits (PERFORMED LOCALLY)

• If Dipstick test is abnormal and clinically significant, urinalysis should be
processed to Central Lab for quantitative assessment

Pregnancy Tests 21
 Urine Pregnancy Test

 Serum Pregnancy Test
• Both forms are available only

when Patient is female of
childbearing potential
• If result of any of the tests is
positive, Patient must be
withdrawn from the study and
End of Study form should be
completed

Pre & Post Salbutamol Central Spirometry 22
 Form available in Visit 1

Screening and Visit 1 –
Rescheduled Spirometry
 Provide all details relating to
the Spirometry tests
performed
 The time to be entered is
the start time of the
assessment as reported in
the BMS report
 Salbutamol intake for
Spirometry only recorded
here (NOT on Rescue
Medication page)

Visit 1- Rescheduled Spirometry 23
 If Inclusion Criterion 5 is not met, system adds automatically Visit 1

– Rescheduled Spirometry folder to repeat the assessment
 Medical Monitor will only complete their review once rescheduled
visit is completed

Eligibility Review 24
 Once all Screening, Rescheduled Spirometry and

Prior and Concomitant Medications forms are To be entered
completed and correct, Site Confirmation form within 2
should be completed working days
 Email alert will be sent to Medical Monitor who

will review eligibility and approve via IWRS Queries at
• Please try to ensure all Screening and Prior and Screening need
Concomitant Medications data is correct to avoid to be closed off
updating after Medical Monitor Review
within 24 hours
• Any delays in closing queries at Screening could
result in delayed Randomization

Randomization 25
 Randomization Form will be populated autmatically based on data

received from IWRS

Screening Failure 26
 For Screening Failures at least the following data must be recorded:
• Date of all visits performed (V0, V1, V1.1, V2 as applicable)

• ICF date
• Demography
• Inc/Exc criteria (the ones actually evaluated by the Investigator)
• Spirometry assessments, if done
• End of study form (including patient’s status and reason for
discontinuation)
• Prior medications (with special focus on previous COPD medications)
• Adverse event and concomitant medications, if present (please include in
the CM only medications related to AE)
All other eCRF pages of the visit should be marked as ‘Inactivated’, even if
the procedures were performed.

26
Background Drug Administration at Clinic 27
 Background Drug prepopulated: Formoterol

 Date and time of administration, number of inhalations and kit
number should be entered.
 Tick ‘not done’ if Background Drug was not administered to
the Patient
• Please note: as Background Drug is not optional ‘Note Done’ should
ideally not be used
• At V1 the intake is at the end of the visit while at other visits is it pre-dose
and after all pre-dose assessments are done

Study Drug Administration 28
 Kit Numbers actually administered at Site should be entered

 For MOON kits, only kit number and dispensations date should be
entered
• Note: the kit numbers actually administered will be reconciled with
kits assigned by IWRS by Chiltern team, therefore please ensure
they are recorded correctly to avoid any queries being raised

Rescue Drug Administration at Clinic 29
The purpose of this form is to collect the intake of salbutamol AT

VISIT and it does not replace the information collected in the
eDiary.
 Rescue Medication prepopulated: Salbutamol

 Enter date and time of administration and number of inhalations
 New log lines can be added

Visit 7 (Week 24/Early Termination) 30
 Visit 7 (Week 24/Early Termination) should be completed:

• 24 weeks (+/- 5 days) after Visit 2; or
• If Patient terminates early in between two planned study visits
Select either ’Visit 7- Week 24’
or ’Early Termination Visit’
 If Patient terminates early during a planned visit, V7 (W24/Early

Termination) pages SHOULD NOT be completed
• Relevant End of Treatment pages will be added dynamically to the current
scheduled visit folder after confirmation that patient is not continuing
 All other folders for Visits not done should be inactivated by using
‘Inactivate Page’ option shown on the top right hand corner of each
eCRF Page

End of Study Form 31
 Date of completion/discontinuation should be specified for ALL

patients entered in eCRF
• For SCREEN FAILURES last date of contact with patient.

• For EARLY WITHDRAWAL, date should match last date of contact with
patient (last planned Visit, Unscheduled or Early Termination Visit date)
• For COMPLETED, date should match V8 date
 FINAL PATIENT STATUS must be specified

 If patient is a SCREENING FAILURE or EARLY WITHDRAWAL,
primary reason must be entered
• AEs reported for the patient will be available in drop down menu

Emergency Unblinding 32
• The treatment code can be opened in an emergency situation, when

Investigator considers essential to know what treatment Patient was taking
• Unblinding of the treatment code will be done through IWRS by specific
username and password. IWRS will promptly notify the Sponsor and the
Clinical Monitor if a treatment code is unblinded
• If this should happen, please, contact Chiesi or Chiltern before unblinding
• Each unblinding should be associated with an appropriate rationale by
Investigator

COPD Exacerbations (1/3) 33
 MILD, MODERATE & SEVERE COPD

exacerbations are entered on the COPD Please remember to
Exacerbation forms (one per form) enter also MILD
available in COPD Exacerbations folder exacerbations
 Details of COPD exacerbations

confirmed in the BMS portal following an
EXACT alert must be confirmed in the
eCRF.

 If any medical procedures were performed to diagnose the

exacerbation, details should be provided in a dedicated field

 If COPD exacerbation meets seriousness criteria, same process is

followed as for AE
• If ’Is the AE serious?’ is answered ’Yes’, seriousness criteria must be
selected and new SAE folder is added to Patient Visit List
• When form is saved, an email to Pharmavovigilance will be sent to start
the reporting process of the SAE

Adverse Events (1/3) 36
 Form launched after confirming that patient experienced AEs

Adverse Events (2/3) 37
 Reported from time of Informed Consent signature until the end of

patient’s participation in the study
 Remember to verify at every visit if patient experienced any ADVERSE
EVENTS
 In case a sign, symptom or disease is already present at the start of the trial
(as noted on the ‘Medical History’ form), but worsens during the course of
the trial, the worsening is considered an Adverse Event and must be
recorded
 In case of worsening of the AE, the worse condition should be recorded
updating the existing record
 COPD exacerbations to be reported on ’COPD Exacerbation’ form, not here
 Seriousness: In case of SAE, a dedicated folder will be generated
 Report 1 event per log line
 Use concise terminology and do not use abbreviations
 Report diagnosis rather than signs and symptoms
 Death is an outcome and not an event: report the event that
caused the death
Adverse Event (3/3) 38
 Relationship to study drug: AE can be related only if occurred

during the treatment period (AE from before the randomization
should not be assessed as related to study drug). In case an AE is
assessed as related to the run-in or rescue medication, please
select “NO” and include a comment on the comment section of the
CRF
 Action taken with the study drug:

• NOT APPLICABLE should be selected if the AE
stops before the first intake of the study drug
• UNKNOWN should be selected if the AE is ongoing
and the Patient is lost to follow up

SAE Reporting (1/2) 39
 SAE Form is triggered after confirming on AE or COPD

Exacerbation form that event is serious

SAE Reporting (2/2) 40
 SAE Report consists of 5 form
• SAE form 2 triggered after SAE form 1 question

below is answered ’Yes’
• SAE form 3 will be only displayed if patient already

attended Screening Visit.
• SAE form 4 available if patient already attended

Randomization visit

Prior & Concomitant Medications (1/3) 41
 Form launched after confirming that patient has taken medication
 If yes, please list in the table: any COPD therapy prior the study
entry, any other medications taken in the 3 months prior to
the Screening Visit, any new Concomitant Medication taken during
the Study, any change (dose, formulation…) in Concomitant
Medication after Visit 1

 Specify:  Every medication and every

• Provide GENERIC NAMES change in dosage, in frequency
when possible; also for or interruption must be recorded
combination products in a separate line
• Include all prescription
medications, non-prescription
medications, alternative
products and nutritional
supplements.
• Enter any use of oxygen or
transfusion products on this
form
Cross-check Inclusion Criteria as for respecting of

wash-out and consistency with Concomitant Diseases

 Indication: Select one of the options for the indication for the
medication
• For any option selected, please select the corresponding pre-populated log
line from the drop down list:
• If information on “Indication” page changes, remember to update Prior &
Concomitant Medications page as well.
e.g. a reason not
reported in the
options above or
for prophylaxis
• Please ensure that all entries are made on the corresponding forms (Medical
History, AE, COPD Exacerbation forms) before completing the Concomitant
Medication form to ensure that the drop down lists display the latest
information

Concomitant Procedures 44
 Form launched after confirming that Patient has had relevant CPs
 Enter data as prompted
If the concomitant procedure started before ICF signature, the

information should be recorded on the Medical History Form

Pneumonia Investigation 45
 A new log line to be added

each time Patient suffers from
pneumonia
 Corresponding AE Number is
to be entered

Unscheduled visits 46
 Unscheduled visits can be added manually as required

 Once added, required forms can be selected by checking the boxes:

Comments 47
 The Investigator Comments log can be used to

record any relevant comment for the conduct of
the study that is not captured in other fields of the
eCRF or to provide further clarification on any
issue
 Please select the visit that the comment is related

to from the drop-down list, specify the page and
enter the comment

eSignatures 48
 Investigator must sign:

• Casebook (when informed to do so by the Monitor)
• SAE forms (within 24 hours of data entry) to comply with ICH GCP 4.9.1
− Both initial and follow-up forms
− Only SAE form 5 needs to be signed
 Any changes or SAE Follow-up after eSignature will invalidate the signature
and the form/casebook must be re-signed

Data Entry Timelines 49
 The following data should be entered into the eCRF within 2

working days of assessments being completed:
• Pre-screening
• Screening
• Rescheduled Spirometry (if done)
• Prior and Concomitant Medications
 All other data should be entered within 3 working days
 Answer queries: 5 working days (Urgent during Screening)
 SAE
• submitted within 24 hours from awareness of the event
• 3 working days for retrospective Data Entry when SAE fax process used
• SAE Form signed within 24 hours after the Data Entry (Initial and Follow-
up report)
• Answer to urgent SAE queries: 1 working day
− notification sent to site and Monitor via e-mail

Data Entry Guidelines 50
 Some forms allow unknown date fields to be entered:

• Day unknown: enter UN
• Month unknown: enter UNK
• Every effort should be made to enter at least a year
 If year is also unknown: enter 0000. Query will fire asking for a
comment on Investigator’s Comments page.
 Comment should be entered and query answered
 Some fields have a Not Done missing data item attached. For these
fields if you enter ND it will populate these items as ND-Not Done.
Example page Vital Signs
 Key to success: log in to review Task Summary often!

 How are patients added to Rave?
Added manually to
Via IWRS System
Medidata Rave

 How quickly should queries at screening be closed off?
Within 24 hours Within 3 days

 When should the ‘Site Confirmation’ Form be used?
When all Screening,

When all Rescheduled
Spirometry and Prior
Screening data is and Concomitant
entered into eCRF Medication data is
entered

 Which of the following triggers the SAE Forms in Rave?
COPD Exacerbation
AE Form Form

 Which SAE forms need to be signed after SAE is reported?
All 5 Forms Form No.5

 On which page should COPD Exacerbations from before Informed

Consent be recorded?
COPD History Medical History

Form Form

 Should a mild exacerbation be recorded on COPD Exacerbation

form?
Yes, all mild

moderate and No, only moderate
severe and severe
exacerbation exacerbations should
should be be recorded
recorded

Agenda 58

EDC Site Support 59
Site Question
or Issue
Study or Protocol Technical Questions

Question or Issues
Medidata 24/7
Monitor
Help Desk

Help Desk Information 60
• Medidata operates 24 hours, 7 days a week (in English)

• Link with access information on every page
 https://tollfree.mdsol.com/
 helpdesk@mdsol.com

Additional Help Resources 61
 Study Specific Help

• eCRF Completion Guidelines
• SAE Completion Guidelines
• Help Text
• Study Monitor
 Online System Help

 Medidata eLearning
 Training presentation slides

62
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PIONEER CCD-06001AA1-01 Study Specific EDC Training

Site User eCRF Training – Rave Version 2016.4

Paulina Awsiukiewicz, eClinical Technical Trainer, Chiltern

8th December 2016 – Krakow, Poland

Quiz at the end of the training!

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

• Broadband Internet Connection

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

 Accept to join the study under tasks

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

 Before site access can be granted, a

Rave EDC Essentials for Investigators

Rave EDC Essentials for Clinical

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

 How do you request access to Rave?

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

 Within what period do I have to activate my iMedidata account

Within 180 days Within 30 days

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

Visit 1 - Screening (Week-2) Available once Visit 0 is

Available after confirmation

Available after confirmation

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

 As soon as recorded in IWRS, the following data will be transferred

Visit 0 PRE- SCREENING:

Important Note: Any changes to imported data must be made in IWRS

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

 Provide date (Month and Year) of first diagnosis

● Provide details of the number of

Documented COPD exacerbation

Medical records, prescriptions, medical

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

 Form available after confirmation that patient has relevant medical

 Description of Diseases and/or Procedures:

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

 After Visit 1(Screening)

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

 If the patient develops suicidal ideation or behavior, he/she should

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

 Blood samples will be analyzed in Central Laboratory

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

 Urinalysis performed by Central Lab at V1, V2 and V7

 Dipstick at other visits (PERFORMED LOCALLY)

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

 Urine Pregnancy Test

• Both forms are available only

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

 Form available in Visit 1

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

 If Inclusion Criterion 5 is not met, system adds automatically Visit 1

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

 Once all Screening, Rescheduled Spirometry and

 Email alert will be sent to Medical Monitor who

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

 Randomization Form will be populated autmatically based on data

eCRF Training – 8th December 2016 – Pioneer IM - Confidential

 For Screening Failures at least the following data must be recorded:

• Date of all visits performed (V0, V1, V1.1, V2 as applicable)