Comparison Chart of Guidelines
For each guideline, the table addresses biobanking development steps in either of the following three levels of detail:
- mentioned, or
- guidelines (detailed enough to dress a protocol/ model), or
- protocols/ model (ready to be followed, to be used)
| Author(s)/organization |
OECD
|
ISBER
|
IARC,
WHO
|
NCI,
NIH,
HHS
|
ABN
|
EHRM
|
RAND
|
INSERM,
AFNOR
|
|
|---|---|---|---|---|---|---|---|---|---|
| Publication date | 2007 | 2008 | 2007 | 2007 | 2007 | 2002 | 2003 | 2008 | |
| Country | International (28 countries) | International Forum based in United States | Worldwide Directors of National Cancer Centres | United States | Australia | Finland | United States | France | |
| Document link |
guidelines
|
guidelines
|
guidelines
|
guidelines
|
guidelines
|
guidelines
|
guidelines
|
guidelines
|
|
| Sample type(s) | Wide: human, animal and plant, and micro-organism | Human: blood, urine, tissues, nails, saliva, breast milk etc | Human: blood (plasma, serum, white blood cells), buffy coat, urine, buccal cells, saliva, bronchoalveolar lavage, bone marrow aspirate, fine needle aspirate, cerebrospinal fluid, semen, cervical and urethral swabs, hair, nail | Human : blood and solid tissue mentionned but not extensively | Human: blood,(serum, plasma, white blood cells, buffy coat), Urine, buccal cells, bone marrow | Human: blood | Human: blood, serum, tumor, tissues | Wide: human | |
| Steps/ areas covered | Infrastructure/ Apparatus | guidelines (appartus maintenance) | protocols (ventilation, temperature, lighting etc..) | protocols (temperature for devices) | guidelines | guidelines | |||
| Biosafety | guidelines | guidelines | guidelines | guidelines | guidelines | ||||
| Staff training | guidelines | guidelines (emergency) | mentionned | guidelines | guidelines | ||||
| Ethics | guidelines | guidelines (privacy rules, consent form, IRB) | mentionned | guidelines (consent form, privacy protection) | Model (consent form) | guidelines | guidelines | ||
| Intellectual Property | mentionned | guidelines | guidelines | ||||||
| Clinical Data Management | protocols | guidelines | guidelines | model of questionnaire, protocols for anthropometric measures | |||||
| Sample Traceability/ Labelling | mentionned | guidelines | guidelines | guidelines | guidelines | guidelines | |||
| Sample type choice | discussion (advantage-inconvenient balance) | discussion (advantage-inconvenient balance) | discussion (advantage-inconvenient balance) | discussion (advantage-inconvenient balance) | |||||
| Sample Collection and Processing | mentionned | guidelines (sample type-dependent) | protocols (sample type-dependent) | guidelines | protocols (sample type-dependent) | protocols | guidelines | mentionned | |
| Sample-derived data management | guidelines (minimum and recommended data set: MDS and RDS) | guidelines | guidelines (minimum information) | guidelines | guidelines | guidelines | guidelines | ||
| Sample Storage | guidelines (sample type-dependent) | guidelines (aliquoting, sample type-dependent) | protocols (sample type-dependent) | guidelines | protocols (sample type-dependent) | protocols | guidelines | mentionned | |
| Quality Control | guidelines (methods validation; sample quality) | protocols (for all SOPs) | guidelines | guidelines | guidelines (materials and sample type-dependent), protocols (RNA) | guidelines | guidelines | protocols (on all topics) | |
| Transportation/ shipping | mentionned | guidelines | protocols | guidelines | guidelines (sample type-dependent) | mentionned | |||
| Funds/ Sustainibility | mentionned | mentionned | guidelines | ||||||
| Access to data/ Transfert | mentionned | guidelines | guidelines | Model (material transfert agreement) | guidelines | guidelines | guidelines | guidelines | |
| Informatics support | guidelines | mentionned (security) | mentionned | guidelines (caBIG system) | guidelines | guidelines | |||
| Other | Recapitulative tables on requirement for each topics (sample type-dependent): maintenance, storage, ethics etc... | Sources websites for every topics (biosafety, shipping, processing protocols etc...) | Table mentionning 16 other biorepository guidelines (ISBER, ABN, OECD, NCI, WHO, RAND, etc...) | protocols for RNA and genomic DNA isolation and stable cell lines generation Laboratory suppliers suggestion (for reagent and apparatus) Suggestion of the sample future use depending on the sample type | Useful guidelines to build a study/biobank: Indicators for risk factors that could be used for background, Sample size discussion, target population, recruitment procedures, duration of surveys, questionnaire administration etc... | Evaluation and comparison of tissues and processes from 12 tissue repositories in USA, Comparison table for all 12 biobanks | Table that lists of all documents required to assess good quality at eahc step Table comparing ISO 9001/2000 norms and BRC standards | ||
| Certification-orientated? | Yes (3 phases) | RAND evaluation | Yes ISO 9001 | ||||||
