Publisher: Medip Academy   (Total: 12 journals)   [Sort by number of followers]

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Intl. J. of Advances in Medicine     Open Access   (Followers: 4)
Intl. J. of Basic & Clinical Pharmacology     Open Access   (Followers: 3)
Intl. J. of Clinical Trials     Open Access   (Followers: 5)
Intl. J. of Community Medicine and Public Health     Open Access   (Followers: 8)
Intl. J. of Contemporary Pediatrics     Open Access   (Followers: 9)
Intl. J. of Otorhinolaryngology and Head and Neck Surgery     Open Access   (Followers: 1)
Intl. J. of Reproduction, Contraception, Obstetrics and Gynecology     Open Access   (Followers: 16)
Intl. J. of Research in Dermatology     Open Access   (Followers: 1)
Intl. J. of Research in Medical Sciences     Open Access   (Followers: 7)
Intl. J. of Research in Orthopaedics     Open Access  
Intl. J. of Scientific Reports     Open Access   (Followers: 4)
Intl. Surgery J.     Open Access   (Followers: 5)
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International Journal of Clinical Trials
Number of Followers: 5  

  This is an Open Access Journal Open Access journal
ISSN (Print) 2349-3240 - ISSN (Online) 2349-3259
Published by Medip Academy Homepage  [12 journals]
  • A comparative evaluation of efficacy of epidural dexmedetomidine and
           fentanyl as adjunct to 0.2% ropivacaine for post-operative analgesia in
           elective abdominal surgeries

    • Authors: Pushpal Gandhi, Mahendra Agrawal, Bhavika Agrawal, Simarn Behl
      Pages: 1 - 5
      Abstract: Background: Epidural analgesia as a central nuraxial technique which involves use of local anesthetics injected into the epidural space to produce a reversible loss of sensation and is the one of the most common regional technique used for lover abdominal and lover limb surgeries epidural analgesia provides excellent pain relief for surgical procedures below the umbilicus. This study compared the efficacy of epidural dexmedetomidine and fentanyl in addition to 0.2% ropivacaine for post-operative analgesia in elective abdominal surgeries.Methods: Total of 150 patients American Society of Anesthesiologists (ASA) I and II between 20-60 years, undergoing major abdominal surgery were included in this study. The patients divided in three groups of 50 patients each. First group R (ropivaciain 0.2% 9 ml with 1ml normal saline) second group RF (ropivacain 0.2% 9 ml with fentanyl 1 ml) and third group RD (ropivaciain 0.2% 9 ml with dexmedetomidine 1 μ/kg).Results: There is no significant difference in age, weight, sex, and ASA grade in all three groups.Hypotension was observed in 4 (8%) patients of R group, 2 (4%) in RD group and 4 (8%) in RF group. The shivering was present in 2 (4%) R group and 2 (4%) in RD group.  Nausea, vomiting was present in R group 2 (4%) and 2 (4%) in RF group. There was no significant difference between the three groups with respect to hemodynamic parameters like heart rate, systolic and diastolic blood pressure and respiratory rate.Conclusions: Dexmedetomidine is a better adjuvant to ropivacaine through epidural route when compared to fentanyl for providing early onset prolonged post-operative analgesia, sedation and stable hemodynamic parameters in intra-abdominal surgeries.
      PubDate: 2021-01-22
      DOI: 10.18203/2349-3259.ijct20205450
      Issue No: Vol. 8, No. 1 (2021)
       
  • Ocular abnormalities in patients with beta-thalassemia: a prospective
           study

    • Authors: Surbhi Gupta
      Pages: 6 - 9
      Abstract: Background: Beta thalassemia is severe genetic blood disorder caused by mutation in the gene encoding for the beta chains of haemoglobin and individuals with beta thalassemia require life-long red blood cell transfusions to survive which leads to hemosiderosis and affects all the organs in the body including eyes. The study aims to study ocular manifestations in these children and its correlation with age and serum ferritin levels.Methods: A descriptive cross-sectional study was done in government medical college Jammu in 2014-2015 on 67 BTM children. Children below 3 years of age and with pre-existing ocular abnormalities, infections were excluded from the study. Ocular examination was done for any major eye abnormality, congenital malformations or trauma. Retinal examination was done using direct and indirect ophthalmoscope, changes were recorded.Results: 47.76% of children belonging to the group: 5-10 years, while only 5.97%, i.e., 4 in number pertained to the age group: >15 years. Lens opacity was seen in 29.85% of children. 31 children showed changes in retinal activity, while decreased visual acuity was also observed in 17 children. Iris was significantly affected in children with serum ferritin >2500 ng/ml. Even greater lenticular changes and opacities were observed in children with higher serum ferritin levels (>4500 ng/ml).Conclusions: As life expectancy for beta-thalassemia patients extends, regular monitoring of the progression of disease and symptoms to detect early changes in their ocular system is recommended, to achieve a better quality of life for this patient group.
      PubDate: 2021-01-22
      DOI: 10.18203/2349-3259.ijct20210078
      Issue No: Vol. 8, No. 1 (2021)
       
  • Comparing the effect of ladies’ finger water with fenugreek seeds water
           on the blood glucose level among subjects with type 2 diabetes mellitus-a
           randomized controlled trial

    • Authors: Radhika R., Navaneetha M., Ravichandran K., Hemavathi P.
      Pages: 10 - 16
      Abstract: Background: The primary aim of managing diabetes is to maintain blood glucose level to prevent diabetes induced complications. Studies showed that ladies finger and fenugreek seeds are blood sugar stabilizer. The objective of this randomized active controlled trial was to assess the effect of ladies finger water versus fenugreek seeds water on the blood glucose level among subject with type 2 diabetes.Methods: Total of 180 study participants were selected and equally assigned to three groups by computer generated randomization. Group 1-received ladies finger water and oral antidiabetic drug (OAD); group 2-received fenugreek seeds water and OAD; group 3-received only OAD for 15 days. Pre and post intervention fasting blood sugar (FBS) was assessed by accu-chek Performa glucometer. Wilcoxon signed rank test; one-way analysis of covariance followed by post hoc test with Bon-ferroni correction was done.Results: Analysis was done based on 168 subjects. There was a significant reduction in FBS level with the mean difference of group 1-21.0 mg/dl (p<0.001), group 2-20.3 mg/dl (p<0.001) and group 3-4.7 mg/dl (p=0.068). No significant difference found between group 1 and group 2 (p=1.00), but significant difference found between group 1 and group 3 (p=0.032); group 2 and group 3 (p=0.012). Both ladies finger water and fenugreek seeds water were superior in reduction of FBS than OAD.Conclusions: Ladies finger water or fenugreek seeds water can be used as adjunct along with OAD to control type 2 diabetes mellitus. 
      PubDate: 2021-01-22
      DOI: 10.18203/2349-3259.ijct20210140
      Issue No: Vol. 8, No. 1 (2021)
       
  • Investigating the prolongation of blood transfusion frequency in
           thalassemic children by omega 3 fatty acid and protein supplementations
           through milk

    • Authors: Amol Kumar, Preeti Doshi, Ramdas Dahiphale, Ansh Chaudhary, Bhupendra Chaudhary
      Pages: 17 - 21
      Abstract: Background: Thalassemia is an inherited genetic hemoglobin disorder wherein, afflicted child is born when both parents are carriers for defective alpha or beta hemoglobin gene. The thalassemias are the most common genetic disorder on a worldwide basis. The requirement of frequent blood transfusions in these patients pose a substantial burden on the health care system.Methods: A prospective observational study was conducted across 6 months (July 2018-December 2018) in a tertiary care hospital, Pune. The present study included 30 registered patient & their past 6 months record of blood transfusion (esp frequency), previous hemoglobin levels, height & weight. All these parameters were compared 6 months after supplementation with Omega 3 fatty Acids & proteins.Results: Total 16 of 28 patient showed that the average durations between two blood transfusions was increased by minimum 01 day to a maximum of 5 days. The average number of blood bag required was less than required blood bags in the period of pre supplementation. 20 of 28 patients showed a rise in hemoglobin level from a range of 0.5 to 1.2 gm/dl.  Conclusions: In a country like India, with the high frequency of hemoglobinopathies, causing increased burden on the society, it is necessary to control the incidence by effective steps. Low cost and easily administered supplementation by omega 3 fatty acid and proteins may reduce the requirement of repeated blood transfusion along with increase in hemoglobin level. Implementation of carrier screening program offering genetic counseling and prenatal diagnosis followed by selective termination of affected cases would help in preventing the disease.
      PubDate: 2021-01-22
      DOI: 10.18203/2349-3259.ijct20210141
      Issue No: Vol. 8, No. 1 (2021)
       
  • Assessment of the feasibility and potential effectiveness of a
           baby-friendly workplace support initiative in rural Kenya: a study
           protocol

    • Authors: Elizabeth W. Kimani-Murage, Teresia N. Macharia, Eva W. Kamande, Peter M. Gatheru, Hermann P. P. Donfouet, Taddese Alemu, Laura Kiige, Susan Jobando, Lynnette A. Dinga, Betty Samburu, Joyce Atinda, Samuel Watson, Claudia Mitchell, Paula Griffiths, Richard Lilford, Debra Jackson, France Begin, Grainne Moloney
      Pages: 22 - 34
      Abstract: Background: Employment poses a barrier in achieving the World Health Organization’s recommendation of exclusive breastfeeding for the first six months of life. Effective strategies and evidence to improve breastfeeding for women working in the agricultural sector – the main employer for women in Kenya – is lacking. This study aimed to inform (with evidence) the design and implementation of a scalable model of workplace support for breastfeeding in an agricultural setting in Kenya; as well as investigated the model’s potential operational feasibility and potential effectiveness, and its cost-effectiveness.Methods: The study employed a mixed methods approach and participatory methods at the pre-implementation, implementation and post-implementation phases. The pre-implementation phase generated evidence to inform the implementation. Mothers with children under 12 months were interviewed at the pre-implementation (2016) and post-implementation (2018) phase. Managers, supervisors, decision and policy makers, as well as other community members were also targeted. Statistical methods will include analysis of covariance and logistic regression. Additionally, cost-effectiveness and cost-benefit analyses will be done. Qualitative data will be analysed in vivo, using thematic analysis technique.Conclusions: Findings from this study aimed to inform the potential feasibility and potential effectiveness of a baby-friendly workplace support for breastfeeding initiative in an agricultural setting with a goal of improving child nutrition and health. The findings also contribute to policy and practice in Kenya by informing the development of workplace support guidelines.Trial Registration: ISRCTN registry, ISRCTN 64692465; date of registration: 21 December 2016 – retrospectively registered, http://www.isrctn.com/ISRCTN64692465.
      PubDate: 2021-01-22
      DOI: 10.18203/2349-3259.ijct20210142
      Issue No: Vol. 8, No. 1 (2021)
       
  • Cognition and obstructive sleep apnoea in Parkinson’s disease, effect of
           positive airway pressure therapy (COPE-PAP trial): protocol of a
           randomized controlled trial

    • Authors: Annie C. Lajoie, Annie-Louise Lafontaine, Gabriel Leonard, R. John Kimoff, Andrea Benedetti, Ann R. Robinson, Joelle Crane, Marie Létourneau, Marta Kaminska
      Pages: 35 - 42
      Abstract: Background: Parkinson’s disease (PD) is the second most frequent neurodegenerative disease and is associated with cognitive dysfunction. Obstructive sleep apnea (OSA) has been linked with cognitive dysfunction in the general population and in PD. Treatment with positive airway pressure (PAP), can improve cognition in the general population and in patients with other neurodegenerative diseases. However, the effect of PAP therapy on cognitive function has not been well studied in PD.Methods: This randomized controlled trial will assess the effect of 6 months of PAP therapy versus placebo on global cognitive function in PD patients with OSA and reduced baseline cognition. Secondary outcomes will include quality of life and other non-motor symptoms of PD. Exploratory outcomes will be specific domains of neurocognitive function and symptoms of REM sleep behaviour disorder.Conclusions: PD-related cognitive dysfunction often evolves towards dementia and has substantial personal, social and healthcare costs. Few interventions have been shown to improve cognition in PD to date. If positive, results from our study could prove OSA to be a new therapeutic target relevant to cognition and would support more systematic screening for OSA in PD patients with cognitive decline.Trial Registration: Trial registration number is NCT02209363.
      PubDate: 2021-01-22
      DOI: 10.18203/2349-3259.ijct20210143
      Issue No: Vol. 8, No. 1 (2021)
       
  • Efficacy of colchicine in moderately symptomatic COVID-19 patients: a
           study protocol for a double-blind, randomized, placebo-controlled trial

    • Authors: Motlabur Rahman, Mujibur Rahman, Ponkaj K. Datta, Khairul Islam, Pratyay Hasan, Manjurul Haque, Md Imtiaz Faruq, Mohiuddin Sharif, Rifat H. Ratul
      Pages: 43 - 50
      Abstract: Background: Inflammation is playing a major role in the pathophysiology of severe COVID-19 disease. The main causes of mortality are cytokine syndrome and immune thromboembolism. Colchicine is an anti-inflammatory drug but its action is mediated by completely different pathophysiologic routes than that of corticosteroids and non-steroidal anti-inflammatory agents. Colchicine inhibits neutrophil chemotaxis, inhibits inflammasome signaling and reduces interleukin-1β, reduces neutrophil-platelet interaction and aggregation. Colchicine is a readily available, cheap drug, has been used safely for many years. Specific targeted anti-inflammatory drugs like tocilizuma and anakinra are costly. A previous study suggested a significant clinical benefit from colchicine in patients hospitalized with COVID-19. But they did not compare with placebo. So, we have designed this study.Methods: This is a prospective, double-blind, randomized, placebo-controlled clinical trial. The study will be conducted at Dhaka medical college hospital, Bangladesh. Real time-polymerase chain reaction (RT-PCR) positive COVID-19 patients with moderate symptoms will be included in this study. Participants will be randomized into two groups at 1:1 ratio. Patients of one group will be treated with standard treatment along with colchicine for 14 days. The patients in other group will be treated with standard treatment along with placebo for the same duration. The primary outcome of the study will be time to develop clinical deterioration, defined as the time from randomization to a deterioration of two points (from the status at randomization) on a seven-category ordinal scale.Conclusions: Enrolment of participants has begun at the study site. A total of 300 participants will be enrolled.Trial Registration: ClinicalTrials.gov identifier: NCT04527562.
      PubDate: 2021-01-22
      DOI: 10.18203/2349-3259.ijct20210144
      Issue No: Vol. 8, No. 1 (2021)
       
  • Exploration of sedentary behaviour among general practitioners: protocol
           for a mixed methods study

    • Authors: Richard S. Mayne, Nigel D. Hart, Neil Heron
      Pages: 51 - 57
      Abstract: Background: Many general practitioners (GPs) are sedentary for most of their working day. Levels of sedentary behaviour may have been exacerbated by increased use of telemedicine in light of the COVID-19 pandemic, as this is traditionally performed while sitting down. Excessive sedentary behaviour is associated with many adverse health outcomes and increased all-cause mortality. This study will gain quantitative data on levels of sedentary behaviour among GPs and general practice specialty trainees (GPSTs), to identify to what extent general practice is a sedentary occupation, as well as qualitative data regarding the barriers and facilitators to reducing sedentary behaviour in the general practice setting.Methods: The study follows a sequential, mixed-methods model. The first stage will involve the dissemination of a questionnaire survey, where participants self-estimate their sedentary behaviour on a working day and on a non-working day. The second stage will use thigh-worn accelerometers and a sleep/work log to obtain objective data regarding sedentary behaviour among a purposive subset of participants who responded to the questionnaire. The third stage will involve semi-structured interviews with a purposive subset of accelerometer study participants, analysed with the application of a theoretical framework regarding the acceptability of healthcare interventions.Conclusions: This paper outlines a protocol for a sequential, mixed-methods study exploring sedentary behaviour among GPs and GPSTs. Findings of this study will shed light on the new ways of working as a result of the COVID-19 pandemic, which will be relevant to clinicians working in similar primary care settings throughout the world.Trial Registration: ClinicalTrials.gov Identifier: NCT04556695. Date of registration: 21st September 2020. 
      PubDate: 2021-01-22
      DOI: 10.18203/2349-3259.ijct20210145
      Issue No: Vol. 8, No. 1 (2021)
       
  • The prognostic role of immunohistochemical markers in surgical margins of
           Indian patients with oral squamous cell carcinoma- a retrospective study
           protocol

    • Authors: Rajul K. Ranka, Minal S. Chaudhary, Preethi N. Sharma, Madhuri N. Gawande
      Pages: 58 - 63
      Abstract: Background: Positive surgical margins in oral squamous cell carcinoma (OSCC) is an important predictor of recurrence. Unfortunately, recurrence is found in cases with negative surgical margins as well and hence molecular markers are being investigated to identify the tumor cells in negative surgical margins to improve the survival of patients. The study aimed to ascertain the prognostic role of p53, eIF4E and E-cadherin in negative surgical margins and association of their expression with clinical parameters, recurrence, and survival.Methods: India based retrospective cohort study of patients who were surgically treated for OSCC between 2011 and 2014. Thirty patients with negative surgical margins were assessed for this study. Sixty-four negative surgical margins were evaluated using immunohistochemistry with monoclonal mouse p53, monoclonal rabbit eIF4E and monoclonal mouse E-cadherin antibodies.Results: Fisher’s exact test, Fishers Freeman Halton exact test and contingency tables were used to assess the association between recurrence rate and clinicopathologic parameters also any association with the expression of p53, eIF4E and E-cadherin in the surgical margins and each patients’ clinical characteristics. ANOVA (analysis of variance) was used to assess the role of clinicopathologic parameters in survival of the patients. The sensitivity and specificity of each antibody along with positive and negative predictive values were calculated. Kaplan Meier was used for analysis of recurrence and five-year survival. P<0.05 was used to denote a statistically significant difference.Conclusion: This study could help in identification of patients with minimal residual cancer in the surgical margins and might help in better therapeutic management to improve survival of OSCC patients.
      PubDate: 2021-01-22
      DOI: 10.18203/2349-3259.ijct20205922
      Issue No: Vol. 8, No. 1 (2021)
       
  • Clinical trials of anticoagulation in COVID-19: a systematic review

    • Authors: Olivia Tracey, Srinath Ramaswamy, Steven R. Levine
      Pages: 64 - 72
      Abstract: A high prevalence of thrombotic events is observed in coronavirus-2019 (COVID-19). Optimal anticoagulation becomes a critical part of treatment and higher-dose prophylactic anticoagulation is being practiced. Prospective evidence to confirm the safety and efficacy of these regimens is lacking. We performed a systematic review of existing studies of anticoagulation in COVID-19. The ClinicalTrials.gov registry, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), and the EU Clinical Trials Register (EudraCT) were searched from inception to September 1, 2020. PRISMA guidelines were followed. Qualitative and quantitative analysis were performed. We identified 36 clinical studies involving anticoagulation in COVID-19. Most common study location was the United States (n=12, 33%). Thirty studies were randomized-controlled (83%) of which 22 were open-label. Median sample size was 309 (IQR 139-952) and study duration was 233 days (IQR 174-357). Most common study setting was critical and non-critical care (n=21, 58%). Most common single primary outcome was all-cause mortality (n=15, 42%) but thrombotic events represent the overall most common primary outcome (n=28, 77%). Low molecular weight heparin (LMWH) was the most common agent studied (n=25, 69%) followed by unfractionated heparin (UFH) (n=14, 38.8%) and factor Xa antagonists (n=8, 22.2%). Therapeutic-intensity prophylaxis was the most common dosage regimen studied in comparison to routine thromboprophylaxis dose in 76% and 86% of studies with LMWH and UFH respectively. Five studies (14%) used intermediate-dose prophylaxis. Bleeding is studied as an outcome variable in 19 studies (53%). Our review identifies studies of anticoagulation in COVID-19 and the pharmacological agents used, dosage intensities, and the outcomes analyzed. 
      PubDate: 2021-01-22
      DOI: 10.18203/2349-3259.ijct20210146
      Issue No: Vol. 8, No. 1 (2021)
       
  • Predicting of patient’s enrollment to multicentral international
           clinical trials of II–III phase

    • Authors: Svyatoslav S. Milovanov
      Pages: 73 - 78
      Abstract: Many international multicenter trials ending by fail due to fail to recruitment of patients. Objective was to find the integrated and simple value for the assessing the possibility of recruitment in particular sites on the feasibility stage. Design consisted of retrospective review of the selected parameters since feasibility stage to final report of studies conducting in a few sites since 2008 to 2017 year. It was also selected empirical range of the sites. Collection of data was done from the private experience of authors. The integrated and simple values for the assessment of the possibility of recruitment in particular sites on the feasibility stage were calculated. Recruitment of patient as an integrated part of site’s work could be calculated as the beginning of running study on particular site which can lead to increasing of study success and could be used as an embedded value in artificial intelligence for both virtual and real studies. We titled this “calculated type of site on enrollment (CTSE)”.
      PubDate: 2021-01-22
      DOI: 10.18203/2349-3259.ijct20210147
      Issue No: Vol. 8, No. 1 (2021)
       
  • Impact of COVID-19 pandemic on design and conduct of clinical trials:
           developing best practices based on lessons learned for risk and change
           management

    • Authors: Marina A. Malikova
      Pages: 79 - 91
      Abstract: The coronavirus disease 2019 (COVID- 19) pandemic is disrupting clinical research in most of the world. We have seen an immediate impact on clinical trials due to challenges coming from the COVID-19 travel bans, hospitals/clinics’ visitation restrictions, social distancing precautions and shifting operations to work remotely on a short notice. These factors have translated into the issues challenging clinical trials such as operations, milestones, budgets, data integrity, etc. Given the complex risk/benefit considerations associated with each specific clinical trial, there is no single solution to manage the risks in clinical trials conduct due to COVID-19. Each trial is unique with respect to patient population, study drug mechanism of action, concomitant medications, and geographic location needs. It is important to continue to engage the networks and communities to push forward with creative risk mitigation and develop solutions during this challenging time. Risk assessment should be a continuous and living process as the situation evolves over the coming weeks to months. Routine and ongoing cross checks with study teams are already proving to maintain alignment on key timelines, critical risk points and other study specific challenges as we are moving towards de-centralized settings in the conduct of clinical trials. We have analyzed lessons learned and attempted to develop best practices to mitigate risks and adjust clinical research operations during this unprecedented time.
      PubDate: 2021-01-22
      DOI: 10.18203/2349-3259.ijct20210148
      Issue No: Vol. 8, No. 1 (2021)
       
  • Non-alcoholic steatohepatitis: diagnosis, management and challenges in
           clinical trials: an Indian perspective

    • Authors: Ena Lyn R. Ang, Ma Cecilia M. Sison, Saket M. Ghaisas, Rashna C. Cama
      Pages: 92 - 100
      Abstract: Non-alcoholic fatty liver disease (NAFLD) is the most prevalent chronic liver disease worldwide and non-alcoholic steatohepatitis (NASH), its progressive form, is rapidly becoming the leading cause of end-stage liver disease and liver transplantation. There is a huge unmet need in the management of NAFLD and NASH. The key challenge is that NAFLD/NASH remains to be an under recognized disease despite its increasing prevalence, and early diagnosis is crucial to reduce the risk of progression and its consequent complications. In India, cases of NAFLD/NASH may go undetected due to lack of awareness and absence of a structured patient referral pathway. Efforts to increase patient and physician awareness along with standardization of local management guidelines for NAFLD and NASH can help improve patient care in India. Another major concern is the lack of approved NASH therapy; in order to address this issue, there has been a global surge in clinical trials. However, many countries, including India, have encountered challenges in the conduct of these trials related to patient recruitment and retention, lack of validated less invasive diagnostic tests, and the effect of placebo response on trial outcomes. Measures to improve the NAFLD and NASH clinical trial environment can help accelerate the approval and availability of better treatment options for NASH. 
      PubDate: 2021-01-22
      DOI: 10.18203/2349-3259.ijct20210149
      Issue No: Vol. 8, No. 1 (2021)
       
  • Archival and management of clinical trial documents

    • Authors: Mehnaaz Alam, D. Yamini Sai Nikitha, Sai Sugun Jala, Gulam Khaleel Ahmed
      Pages: 101 - 110
      Abstract: Clinical trial documents are all records, in any type which incorporates written, electronic, magnetic, optical records, scans, x-rays and electrocardiograms that describe or record the strategy, conduct and results of an effort, the factors poignant an effort and the actions taken. Such a record is thought as document and method is documentation. The documents collected before, throughout and once clinical trials give proof that the study was conducted, the information collected is correct and valid which the investigator and sponsor conducted the trial in line with ICH GCP tips is thought as Trial master file. because of exaggerated quality of studies, particularly medical specialty studies, and therefore the issue managing paper TMF’s for various departments, most organizations have moved to eTMF. Archiving may be a key demand to guage post trial observance and analysis and to facilitate any analysis before initiation of an effort and deposit strategy should be developed. It includes the subsequent parts documents to be archived, amount of archiving, location, retrieval or access of archived documents, disaster recovery, procedure of clinical knowledge archiving, archiving by an ethics committee, archiving by the investigator. Archiving of trial documents helps to store knowledge safely and firmly for future use with facilities like secure systems and e-back up.
      PubDate: 2021-01-22
      DOI: 10.18203/2349-3259.ijct20210150
      Issue No: Vol. 8, No. 1 (2021)
       
 
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