These organizations obtain ethical approval for general collection protocols for sample types that they know are commonly required by many different researchers. Having this type of general collection protocol is common practice for many academic/hospital biobanks and commercial biospecimen providers. In this case, samples are generally being provided to multiple different researchers and companies, for many different research uses. Within the category of prospective collections, there are two types of collections that occur: ongoing and custom.Īn ongoing collection is one where the IRB/IEC approval for a general collection protocol is already in place, and sample collection is ongoing. For example, they require more subject/sample data than is available, or they need multiple samples per subject, or their intended research use of the samples is not covered under the ethically approved uses of the samples. The samples that are available in stock do not meet their specific requirements.The samples or disease/indication they are looking for is rare.FFPE blocks, or frozen samples), but they are not able to find them already existing in a biobank/biorepository or through a commercial biospecimen provider. fresh whole blood samples, fresh tissue samples, etc.Ģ. There are two main instances where a researcher would require a prospective collection of samples:ġ. The results of the second reading by BioClinica will be forwarded to investigation center, which will include them in the patient's record.A prospective collection is the collection of biospecimens from subjects in the future (ie. In case of connection failure from the participating centers, MRI scans will be sent by post.ĭata from this second reading by BioClinica will be retrieved for analysis. This patient identification number will be predefined and attributed to the patient's MRI when the patient is included in the study.Ĭopies of MRIs and coded will be sent securely at BioClinica center for analysis. In case the second reading provides additional data to the first reading, as any new comments or discordant diagnosis, the investigating doctor will integrate these data as soon as he has knowledge of them in the medical care of the patient.Įxcept the data from the second reading of MRIs by BioClinica, all data defined above, will be collected in the case report of the study, from the patient's medical record.įor the second centralized reading of the MRIs, the MRIs will be transmitted as follows: the investigation center will make a copy on Compact Disc - Read Only Memory (CD-ROM) of each MRI collected for the study needs, and will replace the identity the patient by an identification number whose correspondence with the patient's identity is only known by the investigation center. This second reading of MRIs will particularly provide quantitative data not available initially in the patient records, such as Bone Marrow Burden (BMB) score at the lumbar spine and femur, and liver and spleen volumes. ![]() The collected MRIs will be subject to a second reading, which will be conducted centrally by a medical image processing center (BioClinica).
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