Application form for access to data and biological samples Ref. no

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1 Application form for access to data and biological samples Ref Project title: Applicant: Other partners taking part in the project Names and work addresses: Investigation of preventable risk factors for miscarriage in Danish women Name: Jørn Olsen Address: Aarhus University Hospital, Olof Palmes Allé 43-45, 8200 Aarhus N, Denmark Bodil Hammer Bech and Anne Marie Ladehoff Thomsen, Department of Public Health, Aarhus University, Denmark + others from the FETOTOX group Project description (max 200 words) The description should contain 1) purpose, 2) method, material, data, 3) publishing and 4) up to 5 key words Udsættelse for nitroserbare lægemidler i graviditet er hyppigt forekommende. Alle disse stoffer har vist tegn på fetotoxicitet, men om dette også fører til en øget aborthyppighed er uklart. Et enkelt dansk studie har vist overraskende stærk association til spontane aborter, og helt friske studier fra USA tyder på, at nitroserbare lægemidler kan øge risikoen for medfødte misdannelser måske også børnecancer. Det er vigtigt at vide, om disse påvirkninger også øger risikoen for føtal død, både fordi det er en alvorlig bivirkning, men også for at kunne tolke gle af de andre studiers effekt korrekt senere. I studiet vil vi bruge DNBCs data om spontane aborter og ventetid til graviditet (TTP) (også et effektmål for tidlige aborter). Hvis der er sammenhænge, vil vi se om denne sammenhæng er relateret til et bestemt eksponeringsvindue tidligt i graviditeten ved brug af case-time-control studier. Key words: Abortion; time to pregnancy; medication; environmental exposures 1

Time schedule: Project start: Data analyses terminated : Final project report: Month SEPT Year 2016 Month Year Month SEPT Year 2020 Please indicate articles planned and their approx title(s): Based

2 Time schedule: Project start: Data analyses terminated : Final project report: Month SEPT Year 2016 Month Year Month SEPT Year 2020 Please indicate articles planned and their approx title(s): Based on the data applied for, I plan to publish Article 1, titel: Nitroserbare stoffer og risiko for spontan abort Project protocol enclosed: yes Interview Data Are you applying for interview data? X yes X Int 1 X Int 2 X Int 3 Int 4 Lifestyle during pregnancy (LDPS) 7-year follow-up 11-year follow-up Selection criteria: All for the drug study Specification of data required: (list of variables to be agreed with the DNBC data manager) Exposure/outcomes Confounders No. of individuals concerned: All 2

3 Biological Specimens Are you applying for biological specimens? yes: Please describe how your study design is adapted to make the best possible use of the biological specimens. Account for the feasibility of the analyses (requirements for transportation, treatment and storages must be taken into consideration). from 1st sample quantity from 2nd sample quantity from 3rd sample quantity Vi vil bruge same procedure og lab (AU Roskilde) som i vore andre Only a minimum quantity of blood necessary for the analyses in question will be handed out. Please te that DNA is t yet available from all participants. DNA must be extracted at Statens Serum Institut. Number of persons, selection criteria, time period: For what kind of analyses? (state purpose and method): Where are the laboratory analyses carried out?: References from the laboratory may be enclosed. Supplementary Data Collection Sample analyses results Will you be collecting supplementary data/biological samples from cohort members, or will new analyses data be generated? In you application to the Danish Data Protection Agency (DDPA) remember to state that you will return supplementary data to the DNBC No X Yes Supplementary data and results from biological analyses, including geme-wide scans must be returned to the DNBC database after approval from the DDPA - and be made available for other scientists. If you are contacting DNBC participants by mail, this contact must be initiated by the DNBC secretariat. Which kind of data/biological samples? interview/questionnaire (to be enclosed) 3

4 linkage with other registries (please specify) biological specimens (please specify) DNBC Application Form How many individuals will be concerned? During which time period will collection take place? Other Approvals Is your project/data collection approved by: Danish Biomedical Research Ethics Committee X yes (copy of approval to be enclosed) KEA , lbnr 366 For your information: The DNBC is approved under with the DDPA. Inform the DDPA about this number when you submit your project application to the DDPA. The Danish Data Protection Agency X yes (copy of approval to be enclosed) Finances The invoice for the data file should be sent to: Name: Jørn Olsen Address: : Aarhus Universitetshospital, Klinisk Epidemiologisk Afdeling, Olof Palmes Allé 43-45, 8200 Aarhus N EAN-nr.: Fakturaen skal mærkes: 3255 Jørn Olsen Is the project fully financed? X No Yes, amount: Name of the funding person/organisations: Invationsfonden 4

5 Date and signature Date and signature: May 17, 2016 Updated sept 2018 Save the application form to your harddisk and mail to together with your protocol and other relevant documentation. Please state the applicant s name and date clearly in the protocol. 5

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Application form for access to data and biological samples Ref. no

Application form for access to data and biological samples Ref. no 2016-16 Project title: Applicant: Other partners taking part in the project Names and work addresses: Investigation of preventable risk