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Risk Category

Risk

Cause/trigger

Implication

Chances

Mitigation

Materialized?

Scope

Assay examples insufficient to answer business questions

Planning failure

High - may lead others to think the project is useless

Medium

Focus on high-value business questions during elaboration.

Iterative assay selection during implementation of the pilot.

No

Scope

List of business questions may be too broad for the pilot project

Planning failure

Medium

High

Prioritize business questions deeper.

Define a threshold (number or per cent) of business questions that could be answered for the project to be called an overall success.

No

Vendor

Providers not able or not willing to take on the pilot project due to lack of technology, resourcing, or small scope of the pilot

Market

High - may not be able to execute the pilot if this event occurs

Low. At least one provider has expressed interest.

Explore licensing of the tool from CDD or another vendor and driving the annotation work with individual contractors. This in turn may have quality and timing implications.

No

Vendor

Market may be too small with only a few providers, and the RFI may result in only a single qualified provider. This may result in unfavorable pricing and terms and conditions of contract

Market

Medium

Medium

Same as above

No

Vendor

If the cost per annotated assay in the pilot is too high, sponsors may refuse to support the full-scale project

Market

High

Low. Preliminary studies show reasonable costs for this kind of work.

Accept the risk. Finding a typical cost/assay is one of the objectives of the pilot project.

No

Timing

If the pilot is too long, sponsors may lose interest and refuse to support the full-scale project

Planning failure

High

Low

Accept the risk. So far no indication that sponsors desire to cram planning in favor of a deadline.

No

Quality

An oversight of some important terms on our part may result in useless annotation

Planning failure

Medium, because not all annotations would be equally affected

High

Review the ontologies prior to start.

Run annotations in an agile, iterative manner, and add terms if it is determined that the annotation is incomplete (does not have full value) with the already available terms

No

Quality

Annotators may be insufficiently qualified, and we may not be aware of this, resulting in errors

Planning failure

High

Medium

Create a process of training of annotators: first X of the annotations by a new worker are to be reviewed by an already qualified annotator or supervisor.

Create a QC process or require that vendor have an appropriate QC process. (Details TBD).

Create an audit process, where formal qualifications of the annotators (such as academic credentials, work experience) could be reviewed by the project team members, and workers who do not meet the job qualifications are not allowed to annotate assays.

OR require that supplier implement a qualifications review process for workers.

No for Pilot

Open for Phase 1

Quality

Annotators may make mistakes due to time pressure and/or desire to earn more

Bad process

Medium, because not all annotations would be equally affected

Medium

Audit trail that includes record of the identity of the annotator

Hide annotator identity from QC

Implement a payment scheme that rewards annotations that pass QC (in general or on the first try)

Independent double data entry

No for Pilot

Open for Phase 1

Vendor

Vendors may be late with either RFP responses or with the project delivery

Market

Low

Medium

Accept the risk. In the very worst case we’d experience a delay.

No