CCC STUDY Diary Data Protection
Welcome to the information page of the electronic diary (eDiary) app “CCC STUDY Diary”, a diary app to record your symptoms during a clinical trial.
The access data (Login and password) for the use of the STUDY Diary app will only be available in the context of a participation in a clinical study after the trial participant consents to the collection and use of data. A registration without participating in a clinical study is not possible.
If you are participating in a clinical trial that uses the CCC STUDY Diary app, you will receive a printed version of the Patient Information and Consent for Data Collection and Use for your records. For further information on data processing, please refer to this patient information. The Consent form for the Data Collection and Use that you signed before participating in this study always applies to you.
In the following, we would like to demonstrate what data is collected when using the app in the context of a clinical study. The app will not collect and transmit data automatically at any time. The data must be entered by you in the electronic diary and then sent by you. The diary consists of three different questionnaires, which are completed at different times during the study. Completing the individual questionnaires takes about 2 to 3 minutes of your time.
What data are collected and processed?
ClinCompetence Cologne GmbH (the owner of the app), does not collect any data that allows your identification (no tracing of the mobile device used, no tracing of the user) or your localisation when you have installed and using this app. In particular, no telephone numbers or e-mail addresses are collected, forwarded or stored. Incoming IP addresses during data transmission are not stored. The collected data will be pseudonymised and coded with the same identification number of the trial participant as other data entry forms and questionnaires used in the clinical study, in order to ensure correct merging and evaluation of the data.
The CCC STUDY Diary app is only used to collect data that is required for the study. The retrieval of data using the app corresponds to a template that has been approved by the responsible ethics committee. In addition, the time (date and time) of the entry is stored so that it can be assigned to a specific day. The data collected by the STUDY Diary app and processed by ClinCompetence Cologne GmbH is explained in detail below:
Treatment diary
a) You enter the size (diameter in cm) of the wheals and redness you measured after the injections. On the first two injection visits you enter this information for both arms, on the subsequent visits you can choose whether you have received one or two injections. The entries are then made for either one or both arms.
b) You enter ‘yes’ or ‘no’ to indicate whether you have taken an anti-histamine tablet due to side effects.
Report side effect/illness
a) Enter the start date (day and time) and the type of side effect or illness in a free text field.
b) Enter ‘yes’ or ‘no’ to indicate whether you have taken one or more medications due to this side effect or illness. The medication is entered in a free text field with name, dosage, frequency of use and start of use (day and time).
Allergy diary
a) You rate the following symptoms according to their severity as ‘absent’, ‘mild’, ‘moderate’ or ‘severe’:
– Allergy symptoms (sneezing, runny nose, itching nose, blocked nose, watery eyes, red/itchy eyes)
– Asthma symptoms (breathlessness, coughing, wheezing, chest tightness)
b) You can also enter the medication you are taking by clicking on the corresponding medication you are taking
– Allergy medication (antihistamines [tablets, eye drops], nasal corticosteroid spray)
– Asthma medication (asthma inhalation spray)
c) You rate on a visual analogue scale by moving a slider from ‘not bothersome’ to ‘extremely bothersome’ how severe your symptoms were on that day:
– Overall, how much are your allergic symptoms bothering you today?
– How much are your nose symptoms bothering you today?
– How much are your eye symptoms bothering today?
– How much are your asthma symptoms bothering today?
All questions must be answered and the sliders moved before you can send the data.
Installation, user account, necessary permissions of the CCC STUDY Diary App on your mobile device
During the download of the CCC STUDY Diary app from the respective app store, no personal data is collected by ClinCompetence Cologne GmbH. The installation of the app does not require any permissions or authorisations. For more information on data collection during downloading, please refer to the privacy policy of your app store at www.apple.com/privacy or policies.google.com/privacy.
Authorisations: No authorisations (e.g. location, camera, contacts) are required for the provision and correct functioning of the CCC STUDY Diary app. As a study participant, you will receive your personal login data from your physician/investigator. This consists of a unique patient-ID and password. You cannot create a user account or make changes to the account yourself.
Push messages/reminder alerts: You have the option of agreeing to the sending of push messages/messages/notifications (the terms vary depending on your smartphone’s operating system) on your device.
Treatment diary: You will be reminded of the daily entries in the app during the treatment phase. The reminder will be sent at 18:00 on the day of treatment and the two following days. This function can be deactivated and reactivated at any time in the settings of your end device.
Allergy diary: You will be reminded to make daily entries in the app during the allergy pollen season. The 1st reminder is sent at 6.00 pm, the 2nd reminder at 7.00 pm and the 3rd reminder at 9.30 pm each day. As soon as you have made an entry in the allergy diary, further reminders on that day are suppressed. This function can be deactivated and reactivated at any time in the settings of your device.
You can enter your daily entry until 10:00 a.m. on the following day. You cannot make any entries between 10.00 am and 4.00 pm; please enter your allergy symptoms in the app for the day after 4.00 pm.
Transfer of the eDiary data to ClinCompetence Cologne GmbH:
Basically, the entry of data into your diary is possible without an active internet connection. However, in order for the data to be transferred to a server in Germany, an active internet connection is required. The data is transmitted in encrypted form.The amount of data transmitted is very small.
Memory usage and content: When using this app, data relating to your user account (patient-ID and password) are stored on the memory of your mobile device. This is essential for correct functioning. The diary entries are temporarily stored on your mobile device until they are transferred to a server. After successful data transfer, they are automatically deleted from your mobile device. The data entry is transmitted in encrypted form as soon as all the information for the respective questionnaire has been entered and the “submit” button has been clicked and an active internet connection is available. No further use takes place.
Uninstalling the app or deleting your user account:
Please do not uninstall the app from your device until you have finished participating in the study. Please inform your physician/investigator if you no longer wish to participate in the study. Uninstalling the app does not automatically terminate your participation in the study. As soon as your participation in the study has ended, you can of course uninstall the app from your device.
Data security
ClinCompetence Cologne GmbH is aware that the health data collected via the STUDY Diary app is data that requires an increased protection. The data collected from you is protected by technical and organisational measures against loss, destruction, access, modification or distribution by unauthorised persons. To ensure that your data is protected against unauthorised access, security measures are taken when the data is stored on your mobile device, during transmission and for the storage location. The access to your stored data is provided with a separate authentication. The technical administration including the intermediate storage and transmission of data to ClinCompetence Cologne GmbH is carried out by AppCologne GmbH (Fliederweg 127, 51143 Köln, Germany).
The data protection officer is Mr Jörn Dost (datenschutz@appcologne.de). The competent supervisory authority is the ‘State Commissioner for Data Protection and Freedom of Information’, North Rhine-Westphalia, Postfach 20 04 44, 40102 Düsseldorf.
ClinCompetence Cologne GmbH, Theodor-Heuss-Ring 14, 50668 Cologne (info@clincompetence.de) is responsible for data processing.
The following precautions and actions have been taken to ensure that your data is secure:
– The data transfer of the CCC STUDY Diary is encrypted using the HTTPS standard to servers in Germany that are secured with a certificate.
– These servers are hosted by the developer, AppCologne GmbH, on behalf of ClinCompetence Cologne GmbH. All servers used are hosted on the territory of the Federal Republic of Germany.
– Backup: The database is backed up daily on external servers located in Cologne, Germany.
– How the data is stored: The data records are each related to a unique user ID (patient ID), which is not linked to personal data. In line with the concept of data minimisation, no IP addresses, location information or telephone numbers are stored.
– The data is analysed exclusively by ClinCompetence Cologne GmbH.
– Access for the developer and manufacturer of the app is encrypted and secured with a user name and password. Access to the stored data in the backend: There is a purely administrative access for AppCologne GmbH, as well as a download option for ClinCompetence Cologne GmbH. Both accesses can be accessed in encrypted form and are each secured with a user name and password.
These security measures are continuously improved in line with technological developments. Despite regular checks, however, complete protection against all dangers (e.g., criminal cyberattacks) is not possible.
If you have any further questions, please contact our data protection officer Alexander Bugl, Eifelstraße 55, 93057 Regensburg E-Mail: ab@buglundkollegen.de