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.

 

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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.

DADM Conference 2018 Presentations

10. October 2018 14:47 by Ibrahim Kamstrup-Akkaoui in

Dear All,

Thanks for your active participation in the conference and hope that it lived up to your expectations. Remember that you also have an influence on the topics and is welcome to share too.

Please find the presentations from the conference below.

Best regards,

DADM Board

 

DADM_encapsia.pdf (855.39 kb)

DADM_Knowit_Robotics.pdf (1.84 mb)

DADM_PD_Ferring.pptx (716.20 kb)

DADM_PD_Larix.pptm (1.82 mb)

DADM_SAS.PDF (4.07 mb)

Sign Up: DADM Conference 30-Aug-2018

9. July 2018 21:39 by Ibrahim Kamstrup-Akkaoui in

Dear All,

It is a great pleasure to be able to invite you to an exciting event, with national and internationel topic experts (sign-up form is below the program). Thanks for all your great input on topics again this year!

Please sign up immediately and no later than 17-Aug-2018, so that we can arrange the practicalities. Conference fee is 200,- per attendee.

 

DADM Conference 30Aug 2018

Venue

Novo Nordisk
Vandtårnsvej 112
2860 Søborg

Contact

Bo Jørgensen

Payment 200,-

Account number

1551 7952110490 (Danske Bank)

Contact

Lene Haastrup (treasurer)

Schedule

Activity

Speaker(s)

09.00-09.30

Breakfast

All

09.30-09:45

Welcome & Intro

Bo Jørgensen & Frank Jensen

09.45–11.15

PD Handling – how do we do it, process from collection to SDTM?

- Solutions in EDC

- CRO solutions, CTMS or …?

Katja (facilitator)

11.15–11.30

Coffee break

All

11.30–12.15

Data visualization

- Lundbecks solution in Spotfire

Muhammad Uzair Khalid

12.15–13.00

Lunch

All

13.00–14.00

Demo of encapsia:

-        A new generation Clinical Data Suite changing the way Clinical Studies & data is captured, monitored, managed and reviewed.

Cmed 

14.00–14.15

Coffee break

All

14.15–15.15

AI/ML/BigData/Robotics

- SAS Institute: AI/ML – Mapping data into CDISC format

Niels Grønning

15.15–16.15

AI/ML/BigData/Robotics

- Robotics – automating routine assignments/tasks

KnowItDecision

16.15–17.00

Wrap up

All

17.00–18.00

Transportation (walking distance/2 km)

Madhus24,

Søborg Hovedgade 24,

2860 Søborg

All

18.00 -

Dinner

All

 

Looking forward to see you at the event,

DADM Board

 

General Meeting 2018

29. January 2018 08:56 by Ibrahim Kamstrup-Akkaoui in

Dear All,

Thanks for your participation and contribution to the General Meeting 2018.

We believe that this was another succesful and informative event for our members. After the exciting election of the DADM Board, we look much forward to be collaborating with our new member, Peter Aabenhus from Lundbeck.

We would also like to thank the presenters from piinc.dk, Novo Nordisk and Ferring for sharing their tools and thoughts around GDPR and RBM.

Please find the minutes from the meeting attached.

Best regards,

DADM Board

DADM_Generalforsamling_referat_2018.doc (41.00 kb)