CDISC Standard-based Electronic Archiving of Clinical Trials

2009 ◽  
Vol 48 (05) ◽  
pp. 408-413 ◽  
Author(s):  
J. Aerts ◽  
S. C. Semler ◽  
C. Ohmann ◽  
W. Kuchinke
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Trial Data ◽  
The Other ◽  
Master File ◽  
Long Term Storage ◽  
Number Of Patients ◽  
Term Storage ◽  
Study Database

Summary Objectives: Our objectives were to develop, based on the analysis of archived clinical trial documents and data and on the requirements of GCP-compliant electronic archiving, a concept for legally secure and technically feasible archiving of the entire clinical trial, including the essential documents of the trial master file and the study database. Methods: Based on own experiences with CDISC, existing implementations and future developments, CDISC standards were evaluated concerning requirements for archiving clinical studies. Trial master files of a small, medium and large clinical study were analyzed to collect specifications for electronic archiving of records. Results: Two different ways of long-term storage exist for the clinical trial archive: document-oriented archival and data archiving of the study database. The trial master file has a highly complex structure; its different parts can vary greatly in size, depending of the working style of investigators, number of patients recruited, the number of adverse event reports and the number of queries. The CDISC standard ODM is especially suited for archiving clinical trials, because among other features it contains the entire clinical trial data and full audit trail information. On the other hand SDTM is a content standard suited for data warehouses. Two recent developments in CDISC will affect the archival of studies: the further development of ODM in the area of “eCRF submission” and the use of “Electronic Source Data”. Conclusions: The complexity and size of the trial master file requires new solutions. Though ODM provides effective means to archive the study database, it shows still deficiencies, especially for the joint archiving of data and the complex documentation of the trial master file. A concept was developed in which the ODM standard is part of an integrated archiving of the trial data and documents. ODM archiving of the study database enables long-term storage which is GCP-compliant. Archiving of documents of the trial master file in PDF/A, including links and electronic signatures, as well as the storage of selected study data in a data warehouse at the sponsor site in SDTM are the other components of the concept.

scholarly journals Chlorogenic acid content in potato tubers with colored flesh as affected by a genotype, location and long-term storage

2019 ◽  
Vol 65 (No. 7) ◽  
pp. 355-360
Author(s):  
Matyáš Orsák ◽  
Karel Hamouz ◽  
Jaromír Lachman ◽  
Pavel Kasal
Keyword(s):  
Chlorogenic Acid ◽  
Acid Content ◽  
Field Experiments ◽  
The Other ◽  
Potato Tubers ◽  
Flesh Color ◽  
Long Term Storage ◽  
And Storage ◽  
Term Storage

In three-year field experiments, the effect of genotype, flesh color, site conditions and storage on chlorogenic acid content (CAC) in tubers of potato cultivars with purple or red flesh was compared to yellow-fleshed cv. Agria. The results confirmed the significant effect of genotype on CAC. The highest CAC was characteristic on a three-year mean for the purple-fleshed cv. Vitelotte (769.5 mg/kg fresh weight (FW)), i.e. 1.19−2.6 times higher than in the other cultivars. In regard to the effect of flesh color, significantly higher mean CAC levels have been shown for the red-fleshed (2.8 times) and purple-fleshed (3.16 times) cultivars in comparison with cv. Agria (148 mg/kg FW). At the Uhříněves location with a warmer climate and frequent dry periods as compared to the second Valečov location, a higher CAC (1.18 times) was found. Cold storage (4°C, 6 months) resulted in a significant CAC increase varying from 33.2% in the Blaue St. Galler cultivar to 210.6% in the Vitelotte cultivar among all eight evaluated color-fleshed cultivars. On the other hand, the effect of storage on CAC was not evident in the yellow-fleshed Agria cultivar (inconclusive difference against CAC after harvest).

The interrelation of age, permeability and viability of subterranean clover seeds

1969 ◽  
Vol 9 (40) ◽  
pp. 513
Author(s):  
JA Carpenter
Keyword(s):  
Subterranean Clover ◽  
Trifolium Subterraneum ◽  
The Other ◽  
Small Samples ◽  
Long Term Storage ◽  
Common Effect ◽  
Seed Content ◽  
The Common ◽  
Term Storage

The proportions of impermeable seeds, and the viability of permeable and impermeable seeds were measured in samples of Trifolium subterraneum seed that had been stored in a laboratory for up to 34 years. Viability of permeable seed decreased from 99 per cent after storage for 1 year to 8 per cent after 30 years. On the other hand, all impermeable seeds were viable for 1 to 5 years, and 83 per cent were viable after 30 years. The impermeable seed content of the older seed lots was generally higher than that of the younger ones. This difference was related to the high retention of impermeability of the seeds during storage, and to changes in the severity of threshing methods. The impermeable seed content was also correlated positively but poorly with the viability of both permeable and impermeable seeds, independent of the age of the seed. These associations are probably due to the common effect of the environment on all these variables during seed ripening. A small varietal component in each variable was detected. The implications of these data for the long-term storage of small samples of seed are discussed.

The Sowing Value of Tansy Phacelia (Phacelia Tanacetifolia Benth.) Seeds in the Long-Term Storage

2016 ◽  
Vol 20 (3) ◽  
pp. 153-159 ◽  
Author(s):  
Piotr Ponichtera
Keyword(s):  
Life Cycle ◽  
Economic Life ◽  
The Other ◽  
Seed Germinability ◽  
Long Term Storage ◽  
Basic Parameters ◽  
Economic Life Cycle ◽  
Term Storage ◽  
Phacelia Tanacetifolia

AbstractIn 2010 the experiment, which aim was to examine the sowing value of tansy phacelia seeds after eight and nine years of storage, was conducted in the laboratory of the Academy of Agrobusiness in Łomża. The experiment clearly demonstrates that the period of storage of tansy phacelia seeds has an essential impact on the changes of basic parameters of the sowing value. Vetrovska variety had the highest seed germinability among the other varieties of tansy phacelia which were stored for 8 years. At the same time this variety had the highest decrease in seed germinability after 9 years of storage. During the 9-year storage Natra variety showed the highest decrease in thousand seeds weight despite the highest value of this parameter among all the tested varieties immediately after yielding. The results; of the experiment allowed for the conclusion that the economic life: cycle of tansy phacelia seeds is 8 years.

Evaluation of a low-cost procedure for sampling, long-term storage, and extraction of RNA from blood for qPCR analyses

2015 ◽  
Vol 53 (8) ◽  
Author(s):  
Rasmus B. Mærkedahl ◽  
Hanne Frøkiær ◽  
Lotte Lauritzen ◽  
Stine B. Metzdorff
Keyword(s):  
Gene Expression ◽  
Clinical Trials ◽  
Low Cost ◽  
Rna Extraction ◽  
Initial Step ◽  
Rna Integrity ◽  
Long Term Storage ◽  
Significant Cost Reduction ◽  
Term Storage

AbstractIn large clinical trials, where RNA cannot be extracted immediately after sampling, preserving RNA in whole blood is a crucial initial step in obtaining robust qPCR data. The current golden standard for RNA preservation is costly and designed for time-consuming column-based RNA-extraction. We investigated the use of lysis buffer for long-term storage of blood samples for qPCR analysis.Blood was collected from 13 healthy adults and diluted in MagMAX lysis/binding solution or PAXgene Blood RNA tubes and stored at –20 °C for 0, 1, or 4 months before RNA extraction by the matching method. RNA integrity, yield and purity were evaluated and the methods were compared by subsequent analyses of the gene expression levels ofThe MagMAX system extracted 2.3–2.8 times more RNA per mL blood, with better performance in terms of purity, and with comparable levels of integrity relative to the PAXgene system. Gene expression analysis using qPCR of: The MagMAX system can be used for storage of human blood for up to 4 months and is equivalent to the PAXgene system for RNA extraction. It furthermore, provides a means for significant cost reduction in large clinical trials.

scholarly journals Evaluation of the Stability of Bacteriophages in Different Solutions Suitable for the Production of Magistral Preparations in Belgium

Viruses ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 865
Author(s):  
Hans Duyvejonck ◽  
Maya Merabishvili ◽  
Mario Vaneechoutte ◽  
Steven de Soir ◽  
Rosanna Wright ◽  
...  
Keyword(s):  
Acinetobacter Baumannii ◽  
Therapeutic Dose ◽  
Bacterial Species ◽  
The Other ◽  
Manufacturing Processes ◽  
High Importance ◽  
Long Term Storage ◽  
The Stability ◽  
Term Storage

In Belgium, the incorporation of phages into magistral preparations for human application has been permitted since 2018. The stability of such preparations is of high importance to guarantee quality and efficacy throughout treatments. We evaluated the ability to preserve infectivity of four different phages active against three different bacterial species in five different buffer and infusion solutions commonly used in medicine and biotechnological manufacturing processes, at two different concentrations (9 and 7 log pfu/mL), stored at 4 °C. DPBS without Ca2+ and Mg2+ was found to be the best option, compared to the other solutions. Suspensions with phage concentrations of 7 log pfu/mL were unsuited as their activity dropped below the effective therapeutic dose (6–9 log pfu/mL), even after one week of storage at 4 °C. Strong variability between phages was observed, with Acinetobacter baumannii phage Acibel004 being stable in four out of five different solutions. We also studied the long term storage of lyophilized staphylococcal phage ISP, and found that the titer could be preserved during a period of almost 8 years when sucrose and trehalose were used as stabilizers. After rehydration of the lyophilized ISP phage in saline, the phage solutions remained stable at 4 °C during a period of 126 days.

scholarly journals Long-Term Stability of the Electronic Sensor Component of a Digital Pill System in Real-World Storage Settings

2021 ◽  
pp. 875512252098521
Author(s):  
Peter R. Chai ◽  
Georgia Goodman ◽  
Majo J. Bustamante ◽  
Yassir Mohamed ◽  
Jose Castillo-Mancilla ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Gastric Fluid ◽  
Simulated Gastric Fluid ◽  
Once Daily ◽  
Long Term Stability ◽  
Long Term Storage ◽  
System Requirements ◽  
The Stability ◽  
Term Storage

Background: Digital pill systems comprise an ingestible sensor integrated into a gelatin capsule that overencapsulates medication allowing real-time measures of medication ingestion. These systems may improve the manner in which medication adherence can be assessed and supported. Objective: In this investigation, we tested the durability of the ingestible sensor as part of a clinical trial to measure the feasibility and acceptability of the system to measure adherence to once daily tenofovir disoproxil fumarate/emtricitabine (NCT03842436). Methods: Digital pills not dispensed during the study were stored in a pharmacy. Seventeen sensors were selected from digital pills stored for at least 12 months and activated in a simulated gastric environment. A radiofrequency spectrum analyzer and the reader device used in the clinical trial to capture ingestion events were used to measure activation of emitters. A passing evaluation was defined as an energized emitter within 30 minutes of immersion, ability to broadcast a signal for 10 minutes, and successful acquisition by the reader. Results: All ingestible sensors passed the stability test. Mean activation time in simulated gastric fluid was 3.33 minutes (SD = 1.47); emitters remained active for a mean of 47.72 minutes (SD = 1.78). These parameters matched guidelines defined in the ID-Cap system requirements for use in patients. Conclusions: Ingestible sensor components of the ID-Cap system were therefore stable after long-term storage.

Reporting of clinical trial data: Are we fully utilizing the current clinical trial data to help manage the older adult cancer population?

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19546-19546
Author(s):  
J. T. Tam-McDevitt ◽  
W. Tew ◽  
S. Klapper ◽  
R. Hauser ◽  
S. Lichtman
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Treatment Options ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Discussion Section ◽  
Age Related ◽  
Number Of Patients ◽  
Older Cancer Patients

19546 Background: The number of older cancer patients will continue to increase as the population ages. Thus the demand for information on how to manage this population will continue to increase in importance. Clinical trials provide pertinent information to clinicians on treatment options, however, are the current available results matching the needs for the older cancer population? Methods: An evaluation was performed of published clinical trials to determine whether the data was analyzed, reported and discussed using age related criteria. Prospective studies involving 50 or more patients published from 01/2005–12/2006 in the Journal of Clinical Oncology (JCO), Cancer, and the Journal of the National Cancer Institute (JNCI) were reviewed. Results: There were 258 JCO, 58 Cancer, and 17 JNCI articles with the prespecified criteria. The median number of patients enrolled per trial is 212 (JCO), 77.5 (Cancer), and 954 (JNCI). The mean age of patients enrolled for all studies was 59.4 years (range 16 to 93 years). The number (%) of studies which stratified for age is 54 (20.9%) for JCO, 17 (29.3%) for Cancer, and 7 (41%) for JNCI. The number (%) of studies which included age in their analyses is 75 (29%) for JCO, 14 (24%) for Cancer, and 6 (35.3%) for JNCI. Age was mentioned in the discussion section in 40 (15.5%), 8 (13.8%), and 6 (35.3%), JCO, Cancer, and JNCI articles, respectively. Conclusions: The current clinical trials fail to provide ample data which clinicians need to best manage the older cancer population. Since there was a lack of age related analyses, valuable data may have gone unreported. ASCO and other organizations recognize the lack of data on the management of older cancer patients. The underrepresentation of this population in clinical trials certainly contributes to this lack of data. Data mining of these existing studies involving large numbers of patients may provide valuable age related information for clinicians. The continued development of trials involving the older cancer population will aid in increasing our knowledge. We would also like to put forth that journal reviewers and editors should require the incorporation and reporting of age related analyses in studies, especially those involving large number of patients. No significant financial relationships to disclose.

Modelling of Moisture Movement in Wood during Outdoor Storage

2001 ◽  
Vol 6 (2) ◽  
pp. 3-14 ◽  
Author(s):  
R. Baronas ◽  
F. Ivanauskas ◽  
I. Juodeikienė ◽  
A. Kajalavičius
Keyword(s):  
Experimental Data ◽  
Finite Difference ◽  
Climatic Conditions ◽  
Two Dimensional ◽  
Moisture Movement ◽  
Finite Difference Technique ◽  
Long Term Storage ◽  
Space Formulation ◽  
Term Storage

A model of moisture movement in wood is presented in this paper in a two-dimensional-in-space formulation. The finite-difference technique has been used in order to obtain the solution of the problem. The model was applied to predict the moisture content in sawn boards from pine during long term storage under outdoor climatic conditions. The satisfactory agreement between the numerical solution and experimental data was obtained.

Trehalose: a cryoprotectant that enhances recovery and preserves function of human pancreatic islets after long-term storage

Diabetes ◽  
1997 ◽  
Vol 46 (3) ◽  
pp. 519-523 ◽  
Author(s):  
G. M. Beattie ◽  
J. H. Crowe ◽  
A. D. Lopez ◽  
V. Cirulli ◽  
C. Ricordi ◽  
...  
Keyword(s):  
Pancreatic Islets ◽  
Human Pancreatic Islets ◽  
Long Term Storage ◽  
Term Storage
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