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Project Topic
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The training phase of the fellowship has been initiated 6 months after the signing date of the grant agreement, and 5 months after the release of fund. The project was not initiated the same day of the grant agreement because of special needs mentioned below: 1. The Fellow needs extra time to request official study leave that demands an approval from Department, School and College level administation of AAU, the home organization. 2. As the the training phase of the project needs relocation to Switzerland, the Fellow needs to have a work permit to get entry visa. This issue initiates another agreement between the host institution (NIBR) and home organization. As per Annex 1, the Fellow was expected to finalize work package 1 (training phase) by this reporting period. In actual case, the fellow achieved deliverables mentioned upto the mid-way of the training phase of the fellowship i.e. month 6 stay at Novartis Institute of Biomedical Research to this technical periodic report. In general the time line of the project will be pushed by 6 months with no modification of objectives set in the proposal. This delay in initiation of the training phase work package will have impact as well on the initiation of the reintegration phase. The delay in initation of the training phase has got an impact on the Fellows stipend use, which was planned to be initiated once the Fellow got attached at the host institute. With such kind of arrangement, a delay in relocation to a new country by 6 months, has got impact on the total stipend paid for the fellow for the this work package. As per the timeline of the grant agreement, It was planned to utilize the assigned 43,200 Euro for the stipend by the end of this periodic report. However, as the training phase was initiated 6 months after the grant agreement, the allocated amount for stipend (43,200 Euro) will be a payment upto November 2017, i.e. the time for the fellow to finish the training phase. The home institution has paid the stipend for the fellow in a quarter (a payment of three months done once at the begining of every 3 months ). To this effect, the Fellow was paid an amount for the nine months of the trianing plan, 32,400 Euro. This stated amount is mentioned in the financial report as direct personnel cost, from which the indirect cost has been estimated to be 8,100 Euro. Till the time of this periodic report, Services with a value of 3,102 Euro have been obtained but as the payment will be made at the end of the trianing phase of the fellowship,this amount is not included in the financial statement. This payments and payments for the upcoming services will be implemented all together at the end of the training phase of the fellowship. Because of the late initiation of the attachement, the budget utilized is lesser than the expected because of the late initiation of the attachment at host institute.
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Project Results
(after finalisation)
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•Capacity development (Human resources): Completion of advanced trainings at host institution Novartis Institutes for Biomedical Research, Switzerland including standard Good Clinical Practice (GCP) curriculum” courses and “GCP in action” trainings on documentation, informed consent, and investigational medicinal product management
•Capacity development (Human resources, Systems and Infrastructure): Implementation of transferable skills at Addis Ababa University, Ethiopia:
o Support in improving Phase I clinical trial center and its side laboratory that will be involved in therapeutic drug monitoring; SOP development, laboratory facilities set up, including purchasing of electrocardiogram
oSupport to institutional review board in protocol review
oOrganising training workshop on “medicines development and regulation”
oServing as internal reviewer of curriculum for Master’s in clinical trial and PhD in Translational Medicine that are going to be hosted at the Center for Innovative Drug Development & Therapeutic Trials for Africa (CDT-Africa).
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