Confidential Page 1 23/07/2012 /Login page/ LOGIN Username* (i.e., email address) [ ] Password* [ ] Can’t access your account? 1 Login Don’t have an EPR account. Note that you first have to acquire a Specialist Porphyria Centre ID no from your participating Porphyria Specialist Centre. Click here for further details Sign up 1 Reset password protocol
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EPR - Data collection form · 2014-12-15 · Confidential Page 1 23/07/2012 /Login page/ LOGIN Username* (i.e., email address) [ ] Password* [ ] Can’t access your account? 1 Login
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Confidential Page 1 23/07/2012
/Login page/
LOGIN
Username* (i.e., email address) [ ]
Password* [ ]
Can’t access your account?1
Login
Don’t have an EPR account. Note that you first have to acquire a Specialist Porphyria Centre ID no from
your participating Porphyria Specialist Centre. Click here for further details
Sign up
1 Reset password protocol
Confidential Page 2 23/07/2012
/Sign up page /
SIGN UP
S1 Specialist Porphyria Centre ID no.2 * [ ]
� (View only) Your associated Porphyria
Specialist Centre is located here3*
Brussels (Belgium)
Leuven (Belgium)
Sofia (Bulgaria)
Prague (Czech Republic)
Viborg (Denmark)
Helsinki (Finland)
Bordeaux (France)
Paris (France)
Chemnitz (Germany)
Düsseldorf (Germany)
Karlsruhe (Germany)
Munich (Germany)
Budapest (Hungary)
Szeged (Hungary)
Dublin (Ireland)
Tel Aviv (Israel)
Milan (Italy)
Modena (Italy)
Rome (Italy)
San Giovanni Rotondo (Italy)
Rotterdam (The Netherlands)
Bergen (Norway)
Warsaw (Poland)
Moscow (Russia)
Barcelona (Spain)
Madrid (Spain)
Stockholm (Sweden)
Zürich (Switzerland)
Ankara (Turkey)
Cardiff (Wales, United Kingdom)
Leeds (United Kingdom)
London (United Kingdom)
Salford (United Kingdom)
� Language 4 Czech
Danish
Dutch
English
2 Supplied by the porphyria centre and required before first time entry into the EPR. Possibly the first two numbers could
indicate country? 3 This is connected to the Specialist Porphyria Centre ID and is view only
4 Drop-down list. Should default to the official language of the country based on specialist centre ID. This will not appear in
the first draft as there is currently no multilingual support. But this is likely to change so we must prepare for this. Maybe
default to the language corresponding to location based on IP address?
Confidential Page 3 23/07/2012
SIGN UP
Hungarian
Hebrew
Italian
Finnish
French
German
Norwegian
Polish
Russian
Spanish
Swedish
Turkish
Please enter your personal details below to register for a password
S2 First name* [ ]
S3 Middle name [ ]
S4 Surname* [ ]
S5 Professional role (tick all that apply) porphyria specialist (physician)
genetic counsellor
researcher/ site coordinator
general practitioner/ primary care physician
gastroenterologist
haematologist
dermatologist
psychiatrist
neurologist
surgeon
other specialist
allied health professional/ nurse
other
S6 Working place (please edit if different form
the porphyria specialist centre)*
[default to specialist porphyria centre ]*
S7 Institution* [ ]
S8 Address street
suburb/town
state/province
[ ]
[ ] postcode [ ]
[ ] country* [autocomplete]5
S9 Phone number [ ]
5 Defaults to country based on specialist centre ID. The list is autocomplete. Source for country code: UN's Standard country
or area codes and geographical regions for statistical use http://unstats.un.org/unsd/methods/m49/m49.htm. Note Also
available in 6 other languages. Three-digit numerical codes used for statistical processing purposes by the Statistics Division
of the United Nations Secretariat and three-digit alphabetical codes assigned by the International Organization for
Standardization (ISO).
Confidential Page 4 23/07/2012
SIGN UP
S10 Email address6* (username) [ ]
SPAM Filtering software notice7
S11 Password* [ ]
See password requirements8
S12 Password confirmation* [ ]
Sign up
6 The users email address is their username
7 EPR-related information communicated through e-mail may be affected by any e-mail filtering “SPAM” software you have
installed on your computer. EPR uses your e-mail address during the Web-based password request process and for
subsequent communication. To ensure that you receive your password confirmation and other important EPR-related
correspondence, you may want to do one of the following:
- Add the mail ___ domain to your e-mail “safe list”.
- If your settings do not allow you to add e-mail addresses to a “safe list,” use the Help section or contact your e-
mail/internet provider's Customer Support to research your configuration options.
- Disable your e-mail filtering “SPAM” software.
- Choose an e-mail account with the least restrictive spam filters, security settings, etc. 8 Passwords contain at least 8 characters. They must have at least one upper-case letter and one number.
Confidential Page 5 23/07/2012
/Homepage/
<username> I Log out
HOMEPAGE
<Display real time statistics here regarding EPR recruitment rates>
General inclusion criteria
Patients with porphyria, with present or previous symptoms and with a confirmed diagnosis
either by DNA-analysis, or if not tested confirmed by standardised biochemical criteria:
Written informed consent
General exclusion criteria
Participants who are unable to understand the study protocol or unable to give informed
consent and have no legal representative.
Patients without a confirmed diagnosis of porphyria either by standardised biochemical criteria
or by DNA-analysis.
Disease specific inclusion criteria: AIP9 I VP I HCP I ADP I PCT I EPP I XLDPP I CEP I HEP
Quick links to Participant Information and Consent forms10
Children (< 12 years)
Adolescents (12 to 16/18)
Adults (>16/18)
About the EPR I Technical difficulties I Contact us I Disclaimer
9 AIP specific inclusion criteria:
Patients with porphyria, with present or previous symptoms and with a confirmed diagnosis either by DNA-analysis, or if
not tested confirmed by standardised biochemical criteria:
- a urine or plasma PBG value greater than the PBG upper reference limit (URL)
- and a negative plasma fluorescence scanning or wavelength less than 623 nm
- and a fecal coproporphyrin isomer III:I ratio less than 2.0, or if not available, the fecal coproporphyrin less than the
corresponding URL.
Presymptomatic mutation carriers confirmed by DNA-analysis demonstrating inheritance of a disease-related sequence
variant in the hydroxymethylbilane gene. 10
The participant info consent forms are country specific – and routed by help of specialist centre code
Enrolment of a new EPR
participant
Enter data (enrol)
Access or enter new data for
existing EPR participant
Enter data
Enter a new event
View/ edit previous entries
Complete previous entry
Reports
Statistical reports of the EPR
Go To
EPR Protocol (Synopsis)
Overview of your participants
Confidential Page 6 23/07/2012
/Enrolment page/
HOMEPAGE I ENROLMENT I PERSONAL CHARACTERISTICS I DIAGNOSIS I ASSESSMENT I LAB I
FAMILY11
ENROLMENT OF A NEW EPR PARTICIPANT
Patient information and consent form
E1 Register the patient’s date of birth to obtain
an age related print out of the consent
form*12
[dd/mm/yyyy] 13
E2 Written consent given* yes
no14 (the patient cannot be registered)
Previous Next – Creation of an EPR ID No.
Delete and close Save I Save and close
11
Where the tabs feature on the page and how they look will require some thought in web design. The tabs are interactive
in that they show all pages that have been visited and the user will visit. This is dependent on the module. Users can click
backwards, but not forwards (???) 12
Following the registration of the patients DOB the browser’s print method is automatically invoked. Also display message:
“Please store the original consent form in the patient file and provide a copy to the participant. If required send a copy to
your porphyria specialist centre.” 13
After entering the age, the computer is prompted to print the age appropriate PICF. Age groups may change from country
to country according to local ethics regulations 14
Directed to E1
Confidential Page 7 23/07/2012
/EPR ID No. separate window/
CREATION OF THE PATIENT’S EPR ID NO.15
You are about to create the patient’s unique identifier/pseudonym, known as the patient EPR ID no. These
details have been written by the patients in the consent form. PLEASE TAKE GREAT CARE TO ENTER THIS
INFORMATION ACCURATELY, INCLUDING CORRECT SPELLING OF NAMES, as this will avoid the generation of
multiple EPR ID numbers for the same participant. Note that this personal data will never be stored within the
server database.
For more information about generating the EPR ID no, please see (link)16
Participant identification17
ID1 First name at birth* [ ]
ID2 Surname at birth*
OR
If the patient does not have a surname,
specify their patronym
[ ]
ID3 Current surname (if different from above) [ ]
ID4 Date of birth* [dd/mm/yyyy]
ID5 City of birth* [ ]
ID6 Country of birth* [ ]
Optional: you can choose to add the following for your own records
ID7 National ID no. [ ]
ID8 Address street
Suburb/town
postcode
country
[ ]
[ ]
[ ] state/province[ ]
[autocomplete ]18
You will be prompted to print this information after the creation of the EPR ID No. for your confidential records.
15
Appears when user indicates consent is given for a new subject or when a user indicates they have forgotten the
patient’s EPR ID No. This is a separate form opened in a separate window. 16
This links to a separate page. “From these personal data the EPR ID No. is calculated, consisting of a series of <8> digits.
The following personal data are used: first name at birth, surname at birth, date of birth, city of birth and country of birth.
Example: John Smith, born 21.04.1970 in Brighton, United Kingdom. This information results in the EPR ID No. 42-54-91-32.
Importantly, the pseudonym is created on the basis of a so-called ‘cryptographic hash function’. By this mathematical
operation a unique value is assigned during a complicated, one-way procedure. The mathematical algorithm used ensures
that nobody (not even the system programmer) can reconstruct from the result (the EPR ID No.) the information which was
used to generate the EPR ID No. in the first place. The personal data transmitted to generate the EPR ID No. are held only
for the calculation of the EPR ID No. in the working memory of a server. The calculation of the EPR ID No. requires only
milliseconds. Viewing personal data during this time is impossible. Thereafter all data used to create the EPR ID No. are
permanently erased from the working memory of the server so that no identifying details remain; data used to generate
the pseudonym are never stored in any form of permanent memory (e.g. on the hard drive). Following this, all database
entries and every use of data is exclusively carried out under the assigned EPR ID No. 17
To help avoid multiple entries, blanks, upper cases, and special characters are stripped 18
Autocomplete. Source for country code: UN's Standard country or area codes and geographical regions for statistical use
http://unstats.un.org/unsd/methods/m49/m49.htm.
Confidential Page 8 23/07/2012
CREATION OF THE PATIENT’S EPR ID NO.15
It is extremely important that you do not loose this as it is the easiest way to link the exact unique identifying
information to the participant’s EPR ID No. This information is to be kept securely with the patient consent form
in the patient’s personal file.
Create EPR ID No.
19
19 when a doctor clicks 'enter new event' under the 'access or enter new data for existing EPR participant' tile (from the
homepage) and then the 'I have forgotten the patient's EPR ID No.' on the Enter Event page, the EPR prevents them from
creating a new EPR ID No (ie., only allowed to match to a current participant EPR ID No). If they enter data that does not
match an existing EPR ID No. they receive the following error message: 'the participant cannot be found. Are you certain
the patient has been previously entered?'
- if yes, then 'please check for any errors in the above fields marked in red (note: fields are not case sensitive)', and if
incorrect again 'We are sorry, but we still cannot find the participant in the database, and the patient's visit cannot be
currently entered. Please either find the patient's <8> digit EPR ID No., which should be contained in a print out in the
patient's personal file, or contact your EPR coordinator at your local porphyria specialist centre for further assistance. It is
also possible the patient has a print out of their EPR ID No. What would you like to do: () enter the patient's EPR ID No., ()
go back to the homepage, or () leave the EPR.
- if no, then directed to the enrolment of a new EPR participant page.
Confidential Page 9 23/07/2012
/Enter event page/
HOMEPAGE I ENTER EVENT I PERSONAL CHARACTERISTICS I DIAGNOSIS I ASSESSMENT I LAB I
FAMILY HISTORY
ENTER EVENT20
E3 Patient’s EPR ID No.* [ ]21
I have forgotten the participant’s EPR ID No.22
Dates of entry
Date of data entry [dd/mm/yyyy] 23
Dates of previous entries 1.
2.
[dd/mm/yyyy]24
[dd/mm/yyyy]
etc…
Back Next – Personal Characteristics
Delete and close Save I Save and close
20
This is the first page to appear for those entering data for an existing EPR subject. 21
Pre-populated for physicians who have generated the EPR ID No. on the previous page. For physicians entering data for
an existing patient, if they enter data that does not match an existing EPR ID No. they receive an error message, telling
them 'the participant cannot be found. You can find the number in a print out in the patient's personal file. Either try
entering the number again, or click on ‘I have forgotten the participant’s EPR ID No.’ and re-enter their information as
written on their consent form. 22
This is only displayed if the EPR ID No. has not been prepopulated (i.e., only for users entering data for an existing EPR
subject). Users who have forgotten the EPR ID No. are directed to ‘Creation of the Patient’s EPR ID No.’ page. They are also
flagged in the database for quality assurance to ensure they have not made a mistake when re-entering the data.
If this is selected, the EPR prevents the user from creating a new EPR ID No (ie., only allowed to match to a current
participant EPR ID No). 23
Recorded automatically 24
If relevant
Confidential Page 10 23/07/2012
/Personal characteristics page/
HOMEPAGE I ENROLMENT I PERSONAL CHARACTERISTICS I DIAGNOSIS I ASSESSMENT I LAB I
FAMILY
PATIENT’S PERSONAL CHARACTERISTICS25
PC1 Date of birth* [dd/mm/yyyy]26
PC2 Sex* female
male
PC3 Country of residence [autocomplete ]27 unknown
Geographical region28 Europe
Eastern Europe
Northern Europe
Southern Europe
Western Europe
Africa
Eastern Africa
Middle Africa
Northern Africa
Southern Africa
Western Africa
Americas
Latin America and the Caribbean
Caribbean
Central America
South America
Northern America
Asia
Central Asia
Eastern Asia
Southern Asia
South-Eastern Asia
Western Asia
Oceania
Australia and New Zealand
Melanesia
Micronesia
Polynesia
unknown
PC4 Family history of porphyria known? yes
no
unknown
PC5 Number of children [ ]29 unknown
25
Administered consecutively, but details from the previous session are prepopulated and editable 26
Prepopulated from previous entry on enrolment page 27
Display default country based on specialist centre ID No. given 28
Not displayed but coded automatically from country (e.g., IF Greece THEN Southern Europe) 29
Family module section will reflect the input given here
Confidential Page 11 23/07/2012
PATIENT’S PERSONAL CHARACTERISTICS25
�30 PC5.1 (If yes) Year of birth – child one [yyyy] 31 unknown
PC6 Total number of pregnancies [ ]32 unknown
If the patient has died
PC7 Date of death* [dd/mm/yyyy]
� PC7.1 Was the death caused by porphyria
or complication of porphyria/
treatment for porphyria?*
yes
no
unknown
� � PC7.1.1 (If yes) Comment [ ]33
� PC7.2 Primary cause of death*34 cardiovascular diseases
hypertensive heart disease
Ischaemicischemic heart
disease
cerebrovascular disease
inflammatory heart disease
other cardiovascular
diseases
rheumatic heart disease
malignant neoplasms
colon and rectum cancers
breast cancer
prostate cancer
liver cancer
hepatocelluar
carcinoma
other primary liver
cancer
metastatic liver
cancer
trachea, bronchus, lung
cancers
melanoma and other skin
cancers
bladder cancer
lymphomas, multiple
myeloma
other malignant neoplasms
respiratory diseases
respiratory infections
unknown
30
Red arrows indicate branching questions 31
Field is expanded based on number of children 32
Field is only expanded if female (contingency question) 33
Text box is expanded according to the input 34
Drop-down list
Confidential Page 12 23/07/2012
PATIENT’S PERSONAL CHARACTERISTICS25
diseases of the digestive system
cirrhosis of the liver
peptic ulcer disease
Other digestive diseases
unintentional injuries
intentional injuries
suicide
other intentional injuries
other, specify [ ]
� PC7.3 Additional comments about cause
of death
[ ]35
Back Next – to diagnosis
Delete and close Save I Save and close
35
Text box is expanded according to the input
Confidential Page 13 23/07/2012
/Diagnosis page 1/
HOMEPAGE I ENROLMENT I PERSONAL CHARACTERISTICS I DIAGNOSIS I ASSESSMENT I LAB I
FAMILY
PORPHYRIA DIAGNOSIS I CLINICAL SETTING CRITERIA I PBG AT DIAGNOSIS I DNA ANALYSIS I
PORPHYRIA DIAGNOSIS 36
D1 Porphyria diagnosis* 37 Acute:
acute intermittent porphyria (AIP)
variegate porphyria (VP)
hereditary coproporphyria (HCP)
ALA dehydratase deficiency (ADP)
Non-acute porphyrias:
porphyria cutanea tarda (PCT)
erythropoietic protoporphyria (EPP)
x-linked dominant protoporphyria (XLDPP)
congenital erythropoietic (CEP)
hepatoerythropoietic porphyria (HEP)
Clinical Status38
D2 Does the patient have current symptoms consistent with
an acute attack of porphyria39 *
yes
no
D3 Has the patient previously had one or more diagnosed