General meeting DADM 10th February 2022

21. February 2022 17:13 by Lene Haastrup in

 

General meeting DADM 10th February 2022

 

 Minutes

 

 

 

 

 

The General meeting was held as a Teams online meeting with participation of 22 people and the meeting was furthermore recorded.

 

 

 

Conductor: Claus Koch Ullmann

 

Reporter: Gitte Kruse             

 

 

 

The notice for the general meeting have been send out in a timely manner according to the valid regulation.

 

 

 

President report

 

Katja Bernstein went through the annual report and informed of all the activities during 2021.  The President report was hereafter approved.

 

 

 

Financial report 2021

 

The financial result was presented by the cashier Lene Haastrup and was hereafter approved without any comments.

 

 

 

Budget 2022

 

The budget was presented by the cashier and membership fee suggested to be the same as for 2020, 350 kr. per person.

 

A calculation error of 51000 was unfortunately discovered during the presentation, but it was mentioned and will be corrected and hereafter the budget was approved.

 

 

 

Election of executive committee

 

Lene Haastrup did not want to continue in the executive committee and discontinued therefore her work as cashier. Thank you very much to Lene for her contribution to the group.

 

 

 

The executive committee as it looks after election is listed below. A few committee members were replaced per request.

 

 

 

  • Katja Bernstein (not on election)
  • Gitte Kruse (not on election)
  • Kim Sonne (not on election)
  • Britt Bech Andersen (re-elected for 2 year)
  • Frank Jensen (re-elected for 2 year)
  • Mette Ravn (re-elected for 2 years)
  • Poul Knoblauch (re-elected for 2 years)
  • Birgitte Olai Milhøj (elected for 1 year to take over Lenes seat in the board)
  • Mette Schledermann Larsen (altenating officer)

 

 

 

  • Anders Mortin was again selected as auditor.

 

 

 

Proposed motions

 

None

 

 

 

Consolidating

 

The executive committee will be consolidated on the next committee meeting.

 

 

 

AOB

 

  • Ibrahim offered to make a presentation regarding handling of imaging / genomics in connection with big data

 

General meeting DADM 10 February 2022

12. January 2022 09:58 by Lene Haastrup in
Dear All,

Announcement/registration for the DADM General Meeting 2022 is now available!
The meeting will be held on the 10-February-2022 from 15:30-17:00. The event will be held online. When you register, you accept that the other participants can see your e-mail and name
After signing, you will get a Teams meeting invitation on the 09-February-2022.
Meeting venue: Teams

Agenda:
General Meeting – (45 mins)
1. Election of chairman
2. The President’s report
3. Presentation and approval of financial report
4. Presentation and approval of budget and activities including endorsement of membership fee
5. Election of Executive Officers, Alternating Officers, and Auditor
6. Proposed motions
7. Miscellaneous

• Break (5 mins)
8. 16.15-17.00 Topic of the evening:
Achieving Data Privacy Via Data Security, Adam Rosen, Stealthbits
Q&A

slides on focus groups

4. May 2021 15:36 by Lene Haastrup in

Dear all

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, fnje@novonordisk.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)

 

DADM Conference 5th of October 2020

6. September 2020 10:37 by Lene Haastrup in

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 danskforeningfordatamanagement@gmail.com

Kind regards 

DADM board

 

 

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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

Venue

Only speakers and the board

 Novo Nordisk, Vandtårnsvej 108

Søborg

Contact

Frank Jensen

 

No dinner

 

Account number

1551 7952110490

(Danske Bank)

Contact

Lene Haastrup (treasurer)

 

Schedule

Activity

Speaker(s)

09.30-09.45

Welcome & Intro

 

Katja Bernstein & Frank Jensen

09.45-12.00

Audit Trail – what is the expectation from DHMA to the Sponsors

(see below)

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)

 

Questions

 

12-13.45

Lunch break

 

13.45-14.30

Cloud Computing – in a GxP context

Questions 

Kasper Nørgaard Andersen, Senior Consultant, AlfaNordic

 

14.30-15.15

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.

Questions 

Director, attorney (CIPP/E) Daiga Grunte-Sonne, Kromann Reumert

 Data_management_and_GDPR.pptx (2.94 mb)

15.15-16.00

Investigator Experience from Participation in a Clinical Study

Investigator Christine Dali

PI_experiences_presentation_Oct_5_2020.pptx (2.36 mb) 

 

 Including questions

 

 

 

 

 

 

 

17:30

 

18:00

 

Dinner cancelled

All

 

 

IB Alstrup, DADM questions raised on beforehand:

Decommisioning:

  • 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)?

Ongoing:

  • 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?

 

 

 

 

 

 

 

 

Presentations from DADM conference 5 October 2020

9. March 2020 13:10 by Lene Haastrup in Presentations

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)

General meeting DADM 26 February 2020 Minutes

4. March 2020 12:36 by Lene Haastrup in General, Meetings

General meeting DADM 26 February 2020

 Minutes

 

 

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.

 

President report

Ibrahim Kamstrup-Akkaoui went through the annual report and informed of all the activities during 2019.  The President report was hereafter approved.

 

Financial result

The financial result was presented by the cashier and was hereafter approved without any comments.

 

Budget 2020

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

Proposed motions

None

Consolidating

The executive committee was consolidated with

Chairman Katja Bernstein

Treasurer Lene Haastrup

Secretary Gitte Kruse.