Spina bifida Stephen D Mark Christchurch Hospital Christchurch.
Auckland City Hospital and Christchurch Hospital …who are now … · Auckland City Hospital and...
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Welcome to…. Wellington Regional Hospital, Waikato Hospital, Rotorua Hospital, Auckland City Hospital and Christchurch Hospital …who are now open to recruitment! PantoCIN: Pantoprazole for delayed CINV Ethics ref. 18 / CEN / 224 NCT 03948477 Issue 02, August 2019 Recruitment by site Background PantoCIN is a phase II, randomised, double-blinded, placebo controlled, crossover trial to assess Pantoprazole’s effectiveness as prophylaxis against delayed Chemotherapy-Induced Nausea and Vomiting (CINV) in patients receiving adjuvant or neoadjuvant breast cancer chemotherapy. The study will recruit 160 patients from sites across New Zealand. It is managed by Cancer Trials New Zealand and funded by: PantoCIN is a PRO study! This study depends on PRO data. Tips to help ensure PRO data compliance: Discuss upcoming questionnaire dates… with the patient (see protocol section 7.1) write the dates down or on the questionnaires in advance, as required Bookmark... website www.HealthObs.com/PantoCin Download the app ...with the patient (use the instructions in your site file) and demonstrate it with the patient. Patient Reported Outcomes (PRO) Well done to the PantoCIN teams at Rotorua Hospital, Tau- ranga hospital, Wellington Regional Hospital and Auckland City Hospital, leading the way with two recruits each! Keep up the good work! We need 160 patients for the PantoCIN study. It would be great to see all sites recruit in August! Be- low is a graph of actual and expected recruitment: Recruitment PantoCIN dataset: source data Do you have a source data form or a helpful tip you’d like to share? Send to us for inclusion in the next newsletter At CTNZ, we have an electronic/paper copy of all the data fields for PantoCIN, this can be used as a source data template, for participants on the study, and to ensure all data fields are collected. If you would like your hospital header/footer added to the document, then contact us. Screening logs Please keep your screening logs up to date, as we will request copies of these periodically. A copy of the log is in section 10 of your Investigator Site file; refer to Study Procedure 004 (ISF, section 13), for guidance on screening for PantoCIN. Rotorua Hospital 2 Tauranga Hospital 2 Wellington Regional Hospital 2 Auckland City Hospital 2 Palmerston North Hospital 1 Waikato Hospital 0 Christchurch Hospital 0 0 20 40 60 80 100 120 140 160 PantoCIN recruitment Planned Actual
Transcript of Auckland City Hospital and Christchurch Hospital …who are now … · Auckland City Hospital and...
Welcome to…. Wellington Regional Hospital, Waikato Hospital, Rotorua Hospital,
Auckland City Hospital and Christchurch Hospital …who are now open to recruitment!
PantoCIN: Pantoprazole for delayed CINV
Ethics ref. 18 / CEN / 224 NCT 03948477
Issue 02, August 2019
Recruitment by site
Background
PantoCIN is a phase II, randomised, double-blinded,
placebo controlled, crossover trial to assess
Pantoprazole’s effectiveness as prophylaxis against
delayed Chemotherapy-Induced Nausea and Vomiting
(CINV) in patients receiving adjuvant or neoadjuvant
breast cancer chemotherapy. The study will recruit 160
patients from sites across New Zealand. It is managed
by Cancer Trials New Zealand and funded by:
PantoCIN is a PRO study! This study depends on PRO data.
Tips to help ensure PRO data compliance:
Discuss upcoming questionnaire dates…
with the patient (see protocol section 7.1) write the dates
down or on the questionnaires in advance, as required
Bookmark...
website www.HealthObs.com/PantoCin
Download the app ...with the patient (use the instructions
in your site file) and demonstrate it with the patient.
Patient Reported Outcomes (PRO)
Well done to the PantoCIN teams at Rotorua Hospital, Tau-
ranga hospital, Wellington Regional Hospital and Auckland
City Hospital, leading the way with two recruits each! Keep
up the good work! We need 160 patients for the PantoCIN
study. It would be great to see all sites recruit in August! Be-
low is a graph of actual and expected recruitment:
Recruitment
PantoCIN dataset: source data
Do you have a source data form or a helpful tip you’d
like to share? Send to us for inclusion in the next
newsletter
At CTNZ, we have an electronic/paper copy of all the
data fields for PantoCIN, this can be used as a source
data template, for participants on the study, and to
ensure all data fields are collected. If you would like
your hospital header/footer added to the document,
then contact us.
Screening logs
Please keep your screening logs up to
date, as we will request copies of these
periodically. A copy of the log is in section
10 of your Investigator Site file; refer to
Study Procedure 004 (ISF, section 13), for
guidance on screening for PantoCIN.
Rotorua Hospital 2
Tauranga Hospital 2
Wellington Regional Hospital 2
Auckland City Hospital 2
Palmerston North Hospital 1
Waikato Hospital 0
Christchurch Hospital 0
0
20
40
60
80
100
120
140
160
PantoCIN recruitment
Planned Actual
PantoCIN: Pantoprazole for delayed CINV
Ethics ref. 18 / CEN / 224 NCT 03948477
Contact us
For general trial management queries please contact us:
Tel: 09 923 4626
Fax: 09 373 7927
www.cancertrialsnz.ac.nz
Focus on data
PantoCIN on Twitter!
News from Twitter @CancerTrialsNZ
follow us for PantoCIN updates!
PantoCIN has two links to access the databases. All patients must be registered on the clinical database before being random-ised. Follow these steps once you have received informed consent:
1) Log in first to EDC entering screening and participant contact and only go to randomisation using the participant number given in the EDC. Once participant is randomised, treatment should start within 3 days
2) Ensure that the participant completes the baseline questionnaires and remind them about the importance of the compliance to study drug and questionnaires in cycle 1.
PantoCIN teleconference
Next teleconference is Wednesday 28 August
This is open to all PantoCIN Team members at participating
sites and provides an opportunity to ask questions or discuss
any aspect of the trial with the PantoCIN Team at CTNZ and to
share experiences of the trial with other sites. We recommend
you participate in these teleconferences.
Join us at CTNZ Annual Scientific Meeting
24 October 2019, Wellington
Contact us for more details
1. PantoCIN Clinical Database
3. PantoCIN Randomisation
database
2. PantoCIN Information Database
Pan
toC
IN
Register consented patients here firstSystem will generate the subject ID
Enter screening data and all clinical data for all next visits
Upon eligibility confirmation, randomise the patient here and receive the allocated study drug
kit numberProvide answers to the questions consistently with
the clinical database (initials, birth date, chemotherapy regimen)
Use the subject ID generated at the Clinical Database
Treatment must start within 3 days following randomisation
Enter patient address and/or phone number to enable questionnaire reminders to be sent by
CTNZEnter questionnaire modality
Enter expected date of chemotherapy Use the subject ID generated at the Clinical
Database
ALEA Electronic Data Capture link
ALEA Drug Supply
Management link
