Maturity Model - Theme 04 Discovery & Translational Research

Theme 04: Discovery & Translational Research

Frameworks and quality standards that are needed to support the development of basic, pre-clinical, and clinical research including innovation and real world data, to translate the knowledge/discovery into the clinical environment for the benefit of the patients.

Established state-of-the-art research platforms are available and reachable for the whole research community.

Level 1

DT111
State-of-the-art research/technical platforms are planned and concrete initiatives are in the process of implementation.

DT112
Organisational support is planned and concrete initiatives are in the process of implementation.

Level 2

DT121
State-of-the-art research/technical platforms are available and in use in parts of the CCI.

DT122
Organisational support is available and in use in parts of the CCI.

Level 3

DT131
State-of-the-art research/technical platforms are available and in use in the whole CCI.

DT132
Organisational support is available and in use for the whole CCI.

DT133
Data on usage of platforms is collected systematically.

Level 4

DT141
Quality assurance programs are in place.

DT142
There is an increase in the usage of platforms in a period of 5 years.

Biobanks are established and accessible to the entire research community within the CCI.

Level 1

DT113
Initial discussions with potential biobanks for research collaborations in the CCI have taken place.

Level 2

DT123
Agreements with biobanks for research collaborations are established and accessible within parts of the CCI.

Level 3

DT134
Biobanks cover most major tumour types .

Level 4

DT143
Biobanks are linked to clinical data.

DT144
There are written agreements that biobanks are accessible within the whole CCI.

DT145
Biobanks cover all major tumour types.

Early phase Clinical Trial Units (CTU) are available and accessible within the CCI.

Level 1

DT114
The minimal required data for early phase clinical trial units is defined.

Level 2

DT124
The neccessary structures needed for early phase clinical trials are available.

DT125
A first in-human-facility is planned and concrete initiatives are in the process of implementation.

Level 3

DT135
Early phase clinical trial studies are open and available within the CCI.

DT136
A first in-human-facility is available within parts of the CCI.

Level 4

DT146
A first in-human-facility is available for the whole CCI.

	Level 1	Level 2	Level 3	Level 4
Established state-of-the-art research platforms are available and reachable for the whole research community.	DT111 State-of-the-art research/technical platforms are planned and concrete initiatives are in the process of implementation. DT112 Organisational support is planned and concrete initiatives are in the process of implementation.	DT121 State-of-the-art research/technical platforms are available and in use in parts of the CCI. DT122 Organisational support is available and in use in parts of the CCI.	DT131 State-of-the-art research/technical platforms are available and in use in the whole CCI. DT132 Organisational support is available and in use for the whole CCI. DT133 Data on usage of platforms is collected systematically.	DT141 Quality assurance programs are in place. DT142 There is an increase in the usage of platforms in a period of 5 years.
Biobanks are established and accessible to the entire research community within the CCI.	DT113 Initial discussions with potential biobanks for research collaborations in the CCI have taken place.	DT123 Agreements with biobanks for research collaborations are established and accessible within parts of the CCI.	DT134 Biobanks cover most major tumour types .	DT143 Biobanks are linked to clinical data. DT144 There are written agreements that biobanks are accessible within the whole CCI. DT145 Biobanks cover all major tumour types.
Early phase Clinical Trial Units (CTU) are available and accessible within the CCI.	DT114 The minimal required data for early phase clinical trial units is defined.	DT124 The neccessary structures needed for early phase clinical trials are available. DT125 A first in-human-facility is planned and concrete initiatives are in the process of implementation.	DT135 Early phase clinical trial studies are open and available within the CCI. DT136 A first in-human-facility is available within parts of the CCI.	DT146 A first in-human-facility is available for the whole CCI.

Level 1

Level 2

Level 3

Level 4

Established state-of-the-art research platforms are available and reachable for the whole research community.

DT111
State-of-the-art research/technical platforms are planned and concrete initiatives are in the process of implementation.

DT112
Organisational support is planned and concrete initiatives are in the process of implementation.

DT121
State-of-the-art research/technical platforms are available and in use in parts of the CCI.

DT122
Organisational support is available and in use in parts of the CCI.

DT131
State-of-the-art research/technical platforms are available and in use in the whole CCI.

DT132
Organisational support is available and in use for the whole CCI.

DT133
Data on usage of platforms is collected systematically.

DT141
Quality assurance programs are in place.

DT142
There is an increase in the usage of platforms in a period of 5 years.

Biobanks are established and accessible to the entire research community within the CCI.

DT113
Initial discussions with potential biobanks for research collaborations in the CCI have taken place.

DT123
Agreements with biobanks for research collaborations are established and accessible within parts of the CCI.

DT134
Biobanks cover most major tumour types .

DT143
Biobanks are linked to clinical data.

DT144
There are written agreements that biobanks are accessible within the whole CCI.

DT145
Biobanks cover all major tumour types.

Early phase Clinical Trial Units (CTU) are available and accessible within the CCI.

DT114
The minimal required data for early phase clinical trial units is defined.

DT124
The neccessary structures needed for early phase clinical trials are available.

DT125
A first in-human-facility is planned and concrete initiatives are in the process of implementation.

DT135
Early phase clinical trial studies are open and available within the CCI.

DT136
A first in-human-facility is available within parts of the CCI.

DT146
A first in-human-facility is available for the whole CCI.

There is a robust support framework enabling translational research and implementation of results.

Level 1

DT211
SOPs for Good Clinical Practice (GCP) are defined.

DT212
A unit or team is designated as a contact point for general data protection regulations.

DT213
Grant support offices are planned and concrete initiatives are in the process of implementation.

Level 2

DT221
SOPs for Good Clinical Practice (GCP) are implemented in parts of the CCI.

DT222
A unit or team designated as a contact point for general data protection regulations is available in parts of the CCI.

DT223
Grant support offices are available for parts of the CCI.

Level 3

DT231
SOPs for Good Clinical Practice (GCP) are implemented in the whole CCI.

DT232
A unit or team designated as a contact point for general data protection regulations is available in the whole CCI.

DT233
Grant support offices are available for the whole CCI.

Level 4

DT241
The support framework enabling translational research and implementation of results is regularly reviewed and updated.

Support for Innovations is available for the entire research community

Level 1

DT214
Initial discussions and explorations regarding technology transfer in the CCI have taken place.

Level 2

DT224
A standardised process for the integration of new innovations and technology is established.

DT225
Collaborations and agreements of interactions with industry partners are established.

Level 3

DT234
An operational Technology Transfer Office (TTO) is established.

DT235
Collaborations and agreements of interactions among academia, industry, and health organisations are established.

Level 4

DT242
Data on number of patents/ DOFIs is collected systematically. (If yes then: Indicate the number of patents)

DT243
Data on the number of spinoffs/startups is collected systematically.

	Level 1	Level 2	Level 3	Level 4
There is a robust support framework enabling translational research and implementation of results.	DT211 SOPs for Good Clinical Practice (GCP) are defined. DT212 A unit or team is designated as a contact point for general data protection regulations. DT213 Grant support offices are planned and concrete initiatives are in the process of implementation.	DT221 SOPs for Good Clinical Practice (GCP) are implemented in parts of the CCI. DT222 A unit or team designated as a contact point for general data protection regulations is available in parts of the CCI. DT223 Grant support offices are available for parts of the CCI.	DT231 SOPs for Good Clinical Practice (GCP) are implemented in the whole CCI. DT232 A unit or team designated as a contact point for general data protection regulations is available in the whole CCI. DT233 Grant support offices are available for the whole CCI.	DT241 The support framework enabling translational research and implementation of results is regularly reviewed and updated.
Support for Innovations is available for the entire research community	DT214 Initial discussions and explorations regarding technology transfer in the CCI have taken place.	DT224 A standardised process for the integration of new innovations and technology is established. DT225 Collaborations and agreements of interactions with industry partners are established.	DT234 An operational Technology Transfer Office (TTO) is established. DT235 Collaborations and agreements of interactions among academia, industry, and health organisations are established.	DT242 Data on number of patents/ DOFIs is collected systematically. (If yes then: Indicate the number of patents) DT243 Data on the number of spinoffs/startups is collected systematically.