4. May 2021 15:36 by Lene Haastrup
Thank you for your great participation in celebration of DADM Anniversary.
Next initiative introduced is creation of focus groups. Three topics are chosen.
If you want to join one of the focus groups, then you send an e-mail to the facilitator below:
Frank, email@example.com, Risk-based data cleaning; 31-May-2021 15:30 to 16:30 on teams
Jennifer, JNNI@lundbeck.com, Audit trail review; 19th May 15.30 to 16:30 on teams
Katja, KABN@lundbeck.com, Sponsor oversight; 26th of May 2021 at 15.30 to 16.30 on teams
By participating in the focus group then you accept that your e-mail address is visible for the other members and the facilitator!
You can participate in one or more groups.
The date for our full day conference is planned to be Thursday 23th of September 2021.
The board is also investigating possibilities to arrange a more social event in June.
Further notice will be given.
The slides from the anniversary are found here
dadm_history_20_final.ppt (2.22 mb)
5. February 2021 16:17 by Lene Haastrup
9. January 2021 15:13 by Lene Haastrup
6. September 2020 10:37 by Lene Haastrup
The availbe powerpoint presentaions are found under each subject in the program below.
Thank you for a good conference.
The DADM board is looking for more subjects to present this year.
If you have any ideas, please mail firstname.lastname@example.org
Despite the situation, DADM is still going strong. The rules in Pharma have forced us to hold the annual conference online. The conference will take place on 5th of October 2020.
We have collected several speakers and exiting topics, as you see in this program
After the event, you are invited for dinner in real life in Lyngby.
DADM Conference 05 October 2020
Only speakers and the board
Novo Nordisk, Vandtårnsvej 108
Lene Haastrup (treasurer)
Welcome & Intro
Katja Bernstein & Frank Jensen
Audit Trail – what is the expectation from DHMA to the Sponsors
Ib Alstrup, DHMA (Lægemiddelstyrelsen)
IBAL_DKMA_QA.pptx (3.20 mb)
Questions and break
Highligths from the new eClinical Forum paper on Audit Trail review
Jennifer Logue Nielsen, Novo Nordisk
ATR_DADM_05OCT2020.pptx (4.40 mb)
Cloud Computing – in a GxP context
Kasper Nørgaard Andersen, Senior Consultant, AlfaNordic
Data protection – in a clinical context
Data management and GDPR - what should you know?
The most recent news on status as a data controller or data processor and joint controllership
Requirements to agreements with suppliers, security breaches and why transfers of personal data to the U.S. may become a material challenge.
Director, attorney (CIPP/E) Daiga Grunte-Sonne, Kromann Reumert
Data_management_and_GDPR.pptx (2.94 mb)
Investigator Experience from Participation in a Clinical Study
Investigator Christine Dali
PI_experiences_presentation_Oct_5_2020.pptx (2.36 mb)
IB Alstrup, DADM questions raised on beforehand:
- How should sponsors document the system functionality? Are PDF files including the data and pictures of how they were gathered (blank CRFs) sufficient?
- Investigators access to data. Is it fine to revoke the access when sponsor have received acceptance of receipt of the hard drive containing the data from sites?
- Audit trail. Is it fine to have this as PDF file only (hard to search for specific data changes)?
- How much review of the audit trail is expected from the regulators? (Please provide examples of which kind of data and reviews you will expect us to look at) Is it sufficient to look for trends ‘by sites’ and ‘by data items’?
New devices/ways of collecting data:
- Before starting working with a new system, what QC is expected to the audit trail functionality? How is this dependent of whether the system is seen as SAAS (Software As A Service)
- BYOD (Bring Your Own Device). What to focus on when documenting why data is collected this way? – When is better patient compliance outweighing the risk for ‘wrong’ data (registered by someone else or local setting changed)?
- Automatic data collection tools (e.g. activity trackers). What to focus on when documenting which data are used? In general a data mining is taking place and the algorithm is not known to the sponsor. Do we need to archive the raw data, or could the data mining result be defined as raw data?
- Any new device. What to focus on when documenting why this device is used. What kind of mitigations are expected to see?
- How are the documentation dependent on the way sponsors use the software? SAAS or sponsor ‘owned’ – and in what category do we see the mobile apps?
9. March 2020 13:10 by Lene Haastrup
Ib Alstrup DKMA Audit trail Review- the expectation from DHMA to the Sponsors: - IBAL_DKMA_QA.pptx (3.20 mb)
Jennifer Logue Nielsen. Novo Nordisk: Highligths from the new eClinical Forum paper on Audit Trail Review ATR_DADM_05OCT2020.pptx (4.40 mb)
Daiga Grunte-Sonne, Kromann Reumert Data Protection - in a clinical context Data_management_and_GDPR.pptx (2.94 mb)
Christine Dali, Orphazyme: Investigator experience from Participation in a Clinical Study PI_experiences_presentation_Oct_5_2020.pptx (2.36 mb)
4. March 2020 12:36 by Lene Haastrup
in General, Meetings
General meeting DADM 26 February 2020
The General meeting was held at Lundbeck with participation of 34 people.
Conductor: Carsten Junge
Reporter: Gitte Kruse
The notice for the general meeting have been send out in a timely manner according to the valid regulation.
Ibrahim Kamstrup-Akkaoui went through the annual report and informed of all the activities during 2019. The President report was hereafter approved.
The financial result was presented by the cashier and was hereafter approved without any comments.
The budget was presented by the cashier and membership fee suggested to remain at 350 kr. per person. The budget for 2020 was approved without comments.
Election of executive committee
The executive committee as it looks after election is listed below. A few committee members were replaced per request.
- Britt Bech Andersen (re-elected 2 years)
- Mette Ravn (re-elected 2 years)
- Frank Jensen (re-elected 2 years)
- Poul Knoblauch (re-elected 2 years)
- Gitte Kruse (not on election)
- Lene Haastrup (not on election)
- Katja Bernstein (not on election)
- Kim Sonne (new committee member. Replaces Bo and is therefore only elected for the remainder of Bo’s election period and will be on election again next year)
- Mette Schledermann Larsen (new committee substitute)
- Bo Roat Jørgensen (left the executive committee)
- Ibrahim Kamstrup-Akkaoui (left the executive committee)
- Lisbet Groes continues as auditor.
Correction of wording in $4
A minor wording in $4 in the regulation regarding compensation, was by mistake not updated. The suggestion it-self was already approved in 2017, so this only relates to the wording in $4. The re-wording was approved.
The executive committee was consolidated with
Chairman Katja Bernstein
Treasurer Lene Haastrup
Secretary Gitte Kruse.