Source data and its source documents are the foundation of clinical research. Proper source data management plays an essential role for compliance with regulatory and GCP requirements. Both paper and electronic source data co-exist in China. Due to the increasing use of electronic technology in pharmaceutical and health care industry, electronic data source becomes an upcoming trend with clear advantages. To face new opportunities and to ensure data integrity, quality and traceability from source data to regulatory submission, this document demonstrates important concepts, principles and best practices during managing source data. It includes but not limited to: (1) important concepts of source data (e.g., source data originator, source data elements, source data identifier for audit trail, etc.); (2) various modalities of source data collection in paper and electronic methods (e.g., paper CRF, EDC, Patient Report Outcomes/eCOA, etc.); (3) seven main principles recommended in the aspect of data collection, traceability, quality standards, access control, quality control, certified copy and security during source data management; (4) a life cycle from source data creation to obsolete is used as an example to illustrate consideration and implementation of source data management.
China ; Data Collection ; standards ; Documentation ; standards ; Information Storage and Retrieval ; methods ; standards

AIM:To observe the efficacy of intravitreal conbercept injection for chronic central serous chorioretinopathy (CSC).METHODS: Nine eyes of 9 patients diagnosed as chronic CSC between October 2015 to May 2016 were treated with an intravitreal injection of conbercept (0.5mg/0.05mL) (six patients were given the same does of intravitreal injection again at 1mo after the first injection).Follow-up observation was at 1, 2, and 6mo after injection.Observed indicators included best-corrected visual acuity (BCVA), intraocular pressure, optical coherence tomography (OCT), fundus fluorescein angiography (FFA), choroidal indocyanine green angiography (ICGA), macular fovea thickness (CMT), subfoveal choroidal thickness (SFCT).RESULTS:Seven of the 9 patients responded significantly to the drug, while 2 patients had no response.The CMT was 373.12±72.43μm at baseline, which decreased significantly to 332.05±67.13μm, 282.24±62.30μm and 225.56±71.08μm at 1, 2 and 6mo after the intravitreal injection.The mean thickness of SFCT was 422.11±64.82μm before treatment.The choroidal thickness of non-responsive patients before treatment was below average, respectively 353μm and 365μm.The SFCT of 1, 2, and 6mo after treatment was 391.45±75.24μm, 365.53±63.07μm, 355.40±66.65μm.Before treatment and 1mo after, there was no significant difference (P=0.074), but there was statistically significant (P<0.01) between those of before and 2mo and 6mo after.The mean BCVA of the prior treatment was 0.53±0.32, the after treatment was 0.65±0.20, there was no different between the two(P>0.05).CONCLUSION: Intravitreal conbercept injection in chronic CSC may have some effect in accelerating subertinal fluid resolution and decreasing the CMT.The SFCT within 6mo after treatment was significantly lower than pretreatment.The SFCT may be an indicator of whether patients respond.

The purpose of this study was to investigate how Zuogui pills from the Kidney-tonifying and Nourishing Yin formula, in combination with the gonadotrophin-releasing hormone antagonist cetrorelix, affected the ovarian local oxidative stress response in decreasing ovarian reserve (DOR) mice. All animal experiments were carried out in accordance with the guidelines and standards established by Jinan University's Experimental Animal Management Committee. Cyclophosphamide (CTX)-treated DOR mice were given Zuogui pills, cetrorelix, or a combination of the two drugs intragastrically. After treatment, there were changes in the estrous cycle, serum sex hormone levels, oxidative stress-related indexes, growth biochemical factor levels, and SIRT1/P53/P21 expression. In comparison to the model group, the Zuogui pills and the cetrorelix+Zuogui pills group had significantly prolonged estrous periods and shortened interestrous periods, and the cetrorelix+Zuogui pills group had a significantly shortened cycle length. Follicle-stimulating hormone (FSH) decreased and estradiol (E₂) increased in all treatment groups compared to the model group, oxidative stress indexes nitric oxide synthase (NOS), nitric oxide (NO), and reactive oxygen species (ROS) decreased, growth biochemical factors brain derived neurotrophic factor (BDNF) and growth differentiation factor 9 (GDF-9) concentrations increased significantly, and leukemia inhibitory factor (LIF) showed no significant change. SIRT1/P53/P21 immunohistochemical results revealed that, when compared to the model group, the expression of SIRT1 increased while the expression of P53 and P21 proteins decreased in all treatment groups, with the cetrorelix+Zuogui pills group having the largest decrease, with significant differences in all indicators. We conclude that cetrorelix combined with Zuogui pills for kidney nourishing and Yin recipe improved the oxidative stress response in the follicle by regulating the SIRT1/P53/P21 pathway, reducing peroxide product production, protecting ovarian function, and regulating ovarian hormone secretion, and its efficacy is superior to that of cetrorelix or Zuogui pills alone.

Aged ; Humans ; Male ; Middle Aged ; Prostatectomy ; Prostatic Neoplasms ; surgery ; Retrospective Studies

OBJECTIVETo express a bioactive fusion protein comprising rat soluble transforming growth factor beta type II receptor and interferon gamma(rsTGFbetaR II-IFN gamma) in mammalian cells.

METHODSmRNA was extracted from rat liver and the sTGFbetaR II-IFN gamma genes amplified by RT-PCR, then the two gene segments were cloned into the same pSecTag2A expression vector, and pSecTag2A/rsTGFbetaR II-IFN gamma recombinant plasmid was obtained, which was later transfected into CHO cells using liposomes. The expression of pSecTag2A/rsTGFbetaR II-IFN gamma in the supernatant was detected by ELISA and Western blotting. The bioactivities of the fusion protein were tested by sTGF betaR II-IFN gamma and IFN gamma bioassays.

RESULTSpSecTag2A/rsTGFbetaR II-IFN gamma transfectants expressed rsTGF betaR II-IFN gamma fusion protein. The purified fusion protein exhibited anti-viral activity and antagonized the proliferation-inhibitive effect of TGFbeta1 on CCL-64 cells. It inhibits the HSC activation in vitro.

CONCLUSIONThe pSecTag2A/rsTGFbetaR II-IFN gamma recombinant plasmid constructed in this study can express bioactive rsTGFbetaR II-IFN gamma fusion protein.

Amino Acid Sequence ; Animals ; Base Sequence ; CHO Cells ; Cloning, Molecular ; Cricetinae ; Eukaryotic Cells ; metabolism ; Genetic Vectors ; Hepatocytes ; metabolism ; Interferon-gamma ; biosynthesis ; genetics ; Molecular Sequence Data ; Plasmids ; genetics ; Protein-Serine-Threonine Kinases ; Rats ; Receptors, Transforming Growth Factor beta ; biosynthesis ; genetics ; Recombinant Fusion Proteins ; biosynthesis ; genetics ; Recombinant Proteins

OBJECTIVETo construct a eukaryotic expression vector encoding the gene of extracellular region of type II transforming growth factor beta receptor (sTGFbetaR II), to express the protein in CHO cell line and to determine its biological activity.

METHODSThe extracellular region (amino acids 1-159) of the human TGFbetaR II cDNA was amplified by PCR from a TGFbetaR II chimeric plasmid,and the eukaryotic expression plasmid pCDNA3.1/myc-his(-)B-sTGFbetaR II(pCDNA-sTGFbetaR II) was constructed by inserting the sTGFbetaR II cDNA into the EcoR I/Hind III-digested pCDNA. The DNA sequence was confirmed by double digestion and the pCDNA-sTGFbetaR II plasmid was transfected into the CHO cell line. The sTGFbetaR II protein was confirmed by Western blotting analysis and its biological function was determined.

RESULTSThe specific protein was observed in western blotting, and the protein abrogated the growth-inhibitory effects of TGF-beta1 on mink lung epithelial cells (Mv1Lu).

CONCLUSIONThe eukaryotic expression plasmid pCDNA-sTGFbetaR II has been successfully constructed and the sTGFsTGFbetaR II protein with biological activity obtained.

Amino Acid Sequence ; Animals ; Base Sequence ; CHO Cells ; Cloning, Molecular ; Cricetinae ; DNA, Complementary ; Eukaryotic Cells ; metabolism ; Genetic Vectors ; Humans ; Molecular Sequence Data ; Plasmids ; genetics ; Protein-Serine-Threonine Kinases ; Receptors, Transforming Growth Factor beta ; biosynthesis ; genetics ; Recombination, Genetic ; genetics ; Transfection

OBJECTIVETo analyze initial response rate of radiotherapy and chemotherapy for early nasal NK/T-cell lymphoma, and its prognostic factors.

METHODSFrom January 1996 to December 2002, 116 patients with nasal NK/T-cell lymphoma were diagnosed pathologically. Immunophenotyping was performed in 50 cases. According to Ann Arbor staging classification, 95 patients were stage I(E) and 21 II(E). Of the 116 patients, 22 received radiotherapy alone, 6 chemotherapy alone and 88 combined modality therapy (CMT), including, 41 radiotherapy followed by chemotherapy, and 47 chemotherapy followed by radiotherapy.

RESULTSThe 5-year overall survival (OS) rate and disease free survival (DFS) rate for all patients was 74.1% and 61.5%, respectively. For stage I(E) and II(E) patients, the 5-year OS rate was 75.1% and 68% (P = 0.45), and DFS rate was 64.7% and 47.8%, respectively (P = 0.07). The 5 year OS rate and DFS rate were 86.5% and 71.5% for patients who achieved complete response (CR), and 18.4% and 17.2% for those who didn't, respectively (P = 0.000). Sixty-three patients were treated with radiotherapy alone or radiotherapy followed by chemotherapy, while 53 with chemotherapy followed by radiotherapy or chemotherapy alone. The CR rate for radiotherapy was 74.6% while for chemotherapy was 20.8% (P = 0.000). The 5-year OS rate and DFS rate were 76.8% and 65.4% for radiotherapy with or without chemotherapy, and 78.8% and 61.8% for chemotherapy followed by radiotherapy (P > 0.05). Multivariate analysis by COX regression showed that CR rate was the only independent prognostic factor.

CONCLUSIONThe CR rate of radiotherapy is much higher than that of conventional chemotherapy. Addition of chemotherapy to radiotherapy do not improve the survival of patients with early stage nasal NK/T-cell lymphoma. Radiotherapy is the primary treatment for stage I and II nasal NK/T-cell lymphoma.

Adolescent ; Adult ; Aged ; Aged, 80 and over ; Child ; Combined Modality Therapy ; Drug Therapy ; methods ; statistics & numerical data ; Female ; Follow-Up Studies ; Humans ; Kaplan-Meier Estimate ; Lymphoma, Extranodal NK-T-Cell ; therapy ; Male ; Middle Aged ; Nasal Cavity ; Nose Neoplasms ; therapy ; Prognosis ; Proportional Hazards Models ; Radiotherapy ; methods ; statistics & numerical data ; Treatment Outcome ; Young Adult

Carcinoma, Adenosquamous ; complications ; diagnosis ; surgery ; Cystectomy ; Humans ; Male ; Middle Aged ; Prostatectomy ; Prostatic Neoplasms ; complications ; diagnosis ; surgery ; Urinary Bladder Neoplasms ; diagnosis ; secondary ; surgery

OBJECTIVETo explore the function and motor pathway of remained cerebral hemisphere by studying motor evoked potential of both upper extremities on patients long term after anatomical hemispherectomy.

METHODSFive patients after anatomical hemispherectomy, who were marked 5 dispersive sites on head to perform transcranial magnetic stimulation. Recording motor evoked potential of target muscles (brachioradialis muscle and abductor pollicis brevis) of both upper extremities respectively when muscle resting and contracting.

RESULTSOnly affected abductor pollicis brevis of case 2 and only affected brachioradialis muscle of case 4 and 5 recorded motor evoked potential when muscle resting. Motor evoked potential of some cases can be recorded simultaneously in homonymous muscles of both sides when muscle resting or contracting.

CONCLUSIONSThere exists motor cortex that controls movement of ipsilateral limbs and also ipsilateral motor pathway of corticospinal connection at patients after anatomical hemispherectomy. It also means that the motor function of affected limbs has potency to recover well after hemispherectomy. The mirror movement after hemispherectomy is possible relate to overlap of both limbs' motor cortex.

Adult ; Evoked Potentials, Motor ; physiology ; Female ; Follow-Up Studies ; Hemispherectomy ; Humans ; Male ; Motor Cortex ; physiopathology ; Postoperative Period ; Transcranial Magnetic Stimulation ; Upper Extremity ; physiopathology

OBJECTIVETo observe the effect of three Chinese medical formulae (Zhifei Mixture I , Zhfei Mixture II, and Zhifei Mixture II) on main and secondary symptoms and signs of children with Totally 70 mycoplasma pneumonia in treating three types of children mycoplasma pneumonia.

METHODSchildren with mycoplasma pneumonia were assigned to the control group (38 cases) and the treatment group (32 case). All patients were intravenously injected with Azithromycin and took Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution. Those in the treatment group additionally took Zhifei Mixture I , Zhfei Mixture II, and Zhifei Mixture Ill by syndrome typing. Their main and secondary symptoms and signs were observed before and after treatment (main symptoms and signs covered fever, cough, abundant sputum, short breath, and anoxia; secondary symptoms and signs covered aversion to cold, heart rate, facial complexion, spirit, appetite, and sweating).

RESULTSSeven patients were lost in this study. Compared with before treatment in the same group, scores for main and secondary symptoms and signs decreased in the treatment group (P <0.01). The therapeutic effect on fever and cough was obviously better in the control group (P <0.01). The main and secondary symptoms and signs were more obviously improved in the treatment group than in the control group (P <0.01). Commpared with the control group, scores for main and secondary symptoms and signs decreased more in the treatment group (P <0.01). Patients' main and secondary symptoms and signs were more obviously improved (P <0.05).

CONCLUSIONSZhifei Mixture combined Western drugs could significantly improve main and secondary symptoms and signs of mycoplasma pneumonia children patients. Its efficacy was superior to that of using Western medicine alone.

Ambroxol ; administration & dosage ; therapeutic use ; Anti-Bacterial Agents ; administration & dosage ; therapeutic use ; Azithromycin ; administration & dosage ; therapeutic use ; Bronchodilator Agents ; administration & dosage ; therapeutic use ; Child ; Clenbuterol ; administration & dosage ; therapeutic use ; Drugs, Chinese Herbal ; therapeutic use ; Expectorants ; administration & dosage ; therapeutic use ; Fever ; Humans ; Pneumonia, Mycoplasma ; drug therapy ; Syndrome