Manage your project

During the research project’s active period, you are required to provide THL Biobank annual project progress report, as well as information about any changes related to the research project, which deviate from the original  research plan and the signed biobank implementation agreement. Some of the changes may require an official update of the research plan, while for other changes a short notification of the biobank is sufficient.

The most common changes and the respective actions required from the research group are described below. Other changes are also possible during the project - please contact THL Biobank for advice.

Project progress reports to THL Biobank

The research group is requested to provide annual progress reports regarding research activities to THL Biobank during the active project period. The report can be provided using  THL Biobank Project Progress Report Form or by a free-form letter from the project PI, which includes the requested information.
THL Biobank Project Progress Report Form (pdf 115 kb)

In the end of the project the project PI is asked to fill out THL Biobank Project Completion Report Form. With the form the completion of the project is confirmed, and the project results and handling of the samples and/or data after the project is reported.
THL Biobank Project Completion Report Form (pdf 113 kb)

Adding new researchers or new institutes to the research group

Changes in the research group can be reported by a letter or e-mail from the project PI to THL Biobank. The request should include:

• Affiliation, role and contact information of the new researcher. In case the new member is a visiting researcher, also information about the home organization is to be provided.

Note that if the study requires register permissions from national register officials, changes in the research group must be reported to the register officials according to separate procedures.

Adding new institutes/organizations to the project requires updating of the biobank agreement. All institutes where individual level data or samples are handled must be parties in the agreement.

Adding a new 'data processor organization' to the project requires an amendment application to THL Biobank, describing the role of the data processor and providing information of the data processing agreement between the data processor and the data controller.

Requesting new variables and/or samples or adding new research cohorts to the study

Additional variables that fall within the scope of the original research plan may be requested and received from the biobank during the project. These can be requested by a signed request letter (PDF) from the project PI to THL Biobank, describing the requested data and a brief reasoning for the request. The access may be granted by an administrative decision, often without need for updating the biobank agreement.

Requesting new variable categories or sample types, or adding new research cohorts to the project requires submitting an amendment application via REMS application system. The project ID of the original permission is to be referred in the application and a PDF copy of the original application is to be added as an attachment. Following the approval of the amendment application, an updated biobank agreement must be signed.

Requesting extension to the project time

Extension to the project time may be requested by a signed letter (PDF) from the project PI to THL Biobank. The request letter should include:

• The title and number of the project
• The duration of the requested extension with short justification for the request
• Short description on what has been accomplished so far in the project
• If relevant, also changes in the project’s research group should be reported

The extension to the project may be granted simply by an administrative decision of THL Biobank. However, in some cases THL Biobank may require updating of the agreement or a new application before the project time can be extended.

Please note that if you need to store the individual level data (back-up) used for a scientific publication for a limited timeframe the project and related agreement are to be valid.

Amendment application in REMS Portal

The changes is the project which require an amendment application to REMS Application Portal include:

• Adding new institute(s)/ organization(s)/ research group(s) / data processor(s) to the project
• Major modifications to the research plan, i.e. adding new aims
• Requesting new sample collections
• Requesting new data categories, adding new sources of data (i.e. linkage to new register)
• Requesting new sample types

Contact information

Please contact us to discuss what actions are necessary for changes in your research project. All contractual notices and additional requests are to be sent to:

admin.biobank (at) thl.fi